Brand Protection is a proactive initiative to protect patient safety, supply chain integrity and brand reputation by identifying and acting on individuals or entities that intend to mislead healthcare practitioners, caregivers, patients, trade organizations or the public at large for their own illegal gain.    

The Senior Manager, Brand Protection reports directly to the Director, Interactive Marketing and is responsible for overseeing the Brand Protection Core Team, managing key external partnerships, directing ongoing surveillance, executing the communication strategies, analyzing the impact of these entities and reporting initiative progress to Commercial leadership.

MAJOR RESPONSIBILITIES:

• Direct online and offline monitoring of suspect products, diversion, trademark infringement, and promotional abuse in the US market, maintain expert familiarity with core industry trends, including customer, competitive and enforcement dynamics in order to adapt and support various aspects of Brand Protection.
• Serve as the single point of contact for orchestrating Brand Protection activities across the Commercial organization.
• Leads a multidisciplinary, cross-functional Brand Protection Core Team that includes Quality, Trade, Security, Commercial Law, Patent Counsel and Customer Operations. 
• Leads the development of a communication plan that keeps both the CLC and the Commercial organization at large appropriately informed of Brand Protection initiatives and progress reports.
• Track online pharmacies selling Genentech products illegally and analyze behaviors relative to Rx requirements, trademark/copyright infringements, product format/packaging and pricing.
• Execute monthly communication strategies (warning letters) and track response to key actions.
• Prioritize monthly targets for suspect product purchase, secure senior management approvals, and oversee the purchase process. 
• Build and manage relationships with key Federal Enforcement Agencies  (FDA OCI, ICE, DOJ) and partner organizations (NABP, PSI, CDC).
• Develop and manage budgets/resource requests for all Brand Protection activities. 
• Serves as a member of the Counterfeit Core Team.

CAPABILITIES:

• Strong leadership presence with proven ability to influence stakeholders at various levels of the organization (both US and Global); capacity to work collaboratively with peers in pharmaceutical industry and engage support/ alignment.
• Ability to build, lead, motivate and represent matrix, cross-functional teams without direct reporting authority.  
• Superior verbal/ written communication abilities with demonstrated success at communicating complex situations and action plans in a simple, structured and easily absorbed manner.
• Willing to champion new ideas or positions to meet key goals and doesn’t abdicate responsibilities.  Can negotiate skillfully in tough situations with both internal and external; U.S. and Global groups.  Is comfortable around, and influential with, higher management.
• Experience in forecasting and building predictive models to understand impact of diversion on legitimate trade channels.
• Basic understanding of online promotional practices, search engine marketing and social media environments.  Understands consumer behavior and response dynamics.
• Strong commitment to patient safety and compliance requirements.  Maintain thorough understanding of U.S. compliance requirements and legitimate channel definitions.

Description - 

An opportunity for a protein biochemist is available to join a chemical biology group in the Department of Early Discovery Biochemistry. The group uses a multidisciplinary molecular approach for target validation. Recent efforts focus on the use of peptide phage display and small molecule tools for modulating protein-protein interactions and fluorescence imaging of cellular proteins. The successful candidate will be responsible for producing proteins and peptides of therapeutic interest and their characterization by analytical methods (affinity purification, RP-HPLC, SDS-PAGE and western analysis). He/she will also investigate the functional mechanism of bioactive ligands by biochemical and cellular assays. This is a basic research position that requires critical thinking, flexibility, multitasking and the ability to learn new techniques.

This position may be filled at an Associate Services Manager or Contract  Manager level.
 
Contract Services Managers are responsible for contract services (including contract set-up, membership and affiliation assignment and maintenance) and/or customer payments in accordance with accuracy and compliance requirements. Customer payments may include responsibilities, as assigned, for processing fees, rebates, discounts and chargebacks, as per the terms of each contract. Additionally, Contract Services Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. Expertise in the processes, calculations, systems and Standard Operating Procedures (SOPs) that support contract services and customer payments is critical to success in this position. Contract Services Managers, by comparison to Associate Contract Services Managers, also have responsibilities for developing complex analyses and reports, reviewing from the work of less experienced team members, performing contract set-up and structure for other team members, managing Internal Control Over Financial Reporting (ICFR) tracking and monitoring activities, and leading projects to improve processes and procedures.

• Acts as a lead SME for assigned contracts, other activities, SPCM Contract Operations systems, processes and SOPs
• Plays a lead role in cross-functional initiatives involving new/updated pricing and contracting strategies, terms, conditions, language and the like 
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current contracting models, pricing, discounts, rebates, chargebacks, compliance and the like. Develops appropriate responses, including recommending changes in complex pricing and contracting strategies, programs and contract administration
• Plays a lead role in development, education, communication, implementation and ongoing maintenance of Contract Operations SOPs, systems, processes, data, reporting templates and the like. Includes serving as a liaison for technology-related projects to ensure systems or enhancements are designed to meet the operational needs of Contract Operations and supporting testing for new or updated systems 
• Works with manager and others to establish appropriate performance metrics for monitoring, evaluating and reporting on contracts, contract performance and other business, legal and regulatory requirements
• Plays a lead role in development and delivery of Contract Operations training; including conducting training for other staff members and, as appropriate, others outside of the department
• As assigned, leads or otherwise participates in and supports other special projects
• As assigned, my perform some or all of the following: perform some or all of the following:
• Enters contract information into departmental systems and databases Performs contract set-up and maintenance. Includes 340B Program Integrity support and assigning customers to appropriate contract groupings and class of trade (membership and affiliations), coordinating and managing contract term reviews
• Collaborates with other departments to determine appropriate pricing eligibility for new managed care customers; identifying customer entities, class of trade and appropriate contract pricing
• Implements departmental changes arising from such things as complex pricing strategies, updates to operating procedures, or internal policies affecting Contract Operations
• Uses relevant contract terms, conditions and other regulations, policies, etc. as well as appropriate systems and tools to evaluate, calculate, validate and process customer payments 
• Prepares payment packets as per the terms of each assigned contract. Ensures packets are routed through to all appropriate partners/stakeholders for review and approval
• Works with Customer Finance and other partners/stakeholders to track customer payments and ensure accurate and timely payments are made to customer accounts. Helping ensure penalties are avoided 
• Develops and evaluates contract performance using approved financial modeling templates
• Completes ICFR tracking and reporting, as per business and legal requirements and departmental policies & procedures
• Prepares, obtains approval for and ultimately publishes departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Performs ongoing membership and affiliate maintenance. May include updating membership/affiliation on an exception basis in accordance with business rules
• Responds to...

Responsibilities:

Works with senior biostatistics staff and clinical monitors on clinical development plans, the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results. As part of a clinical assessment team, collaborates in the preparation and review of clinical assessments. For assigned clinical development project(s), provides statistically sound experimental design and data analysis input to meet project objectives and Health Authority's statistical requirements. Reviews all project protocols, author protocol statistical analysis sections and generate study randomizations. Develops study analysis plans as a team member; lead this effort for selected studies. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, and verify data accuracy and validity. Co-author efficacy analysis results in the clinical study report. Supplies statistical input for filing submissions and in response to FDA questions. Provides support for publications. Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

The MCCO Solutions team in Genentech’s IT Americas organization is looking for a motivated Sr. Software Quality Analyst to lead all aspects of Quality Assurance and QA Testing of technology projects in support of US Commercial Operations.  The Sr. SQA will be responsible for managing the work of assigned Quality Assurance (QA) resources, effectively building and tracking QA Plans and Strategies, and ensuring end-to-end quality in all phases of the project lifecycle.  

Duties:

• Plan and execute functional, performance and stress testing on applications and systems using automation and manual testing
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (Mercury Suite, Selenium, Segue, etc)
• Lead the development of SQA Test Plans, Test Procedures, SQA lab standards and tool requirements
• Identify opportunities for process improvements that streamline development activities while minimizing risk
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage work of onsite and offshore SQA testers as required 

The DAS is responsible for the specifications, acquisition, loading and delivery of non-CRF data including IxRS, laboratory, pK and other data.

Responsible for the production of non-CRF data collection specification documentation 

Defines the study specific non-CRF data handling strategy

Collaborates with SMT to agree on vendor expectations for the collection and transfer of data 

Reviews and refines the technical requirements with service provider to establish the transfer of non-CRF data  

Responsible for establishing appropriate transfer methodology with external data provider

Provides transfer methodology training and documentation on non-CRF data for external vendors.

Responsible for configuring the data loading tools based on data collection specifications

Receives, uploads, confirms and communicates status of test data transfers to validate and accept file format and database structure

Performs verification and resolves data transmission, file format and loading errors with data providers  

Proactively checks all inbound non-CRF electronic data for any potentially unblinding data as defined in the protocol and ensures study integrity by sequestering unblinding data until data release is authorised

Delivers data to external recipients and review bodies via established transfer methodologies

Represent CDM on IxRS sub teams and works with the Study Management Team to develop IxRS specifications and implement the system

Coordinates and plans subfunction activities to meet program-level deliverables and timelines

Develops and maintains the subfunction standards for the studies in a program

Collaborates with Data Modeling Specialists to define study data collection standards for new assessments and collaborates with them to implement new standards

Effectively communicates ideas, project goals and status of work and can present to senior management 

Proactively develops solutions to complex problems requiring the regular use of ingenuity and innovation

Sets targeted timeframes for  deliverables and anticipates potential scenarios that may result in timeline delays; able to influence and negotiate a positive outcome

Proactively develops contingency plans to reduce impact of risks that may occur, to analyze effectiveness of strategies and to monitor and review risks 

Overview:

The Sales Operations Manager role is to support the assigned business unit or franchise with regular and ad hoc business analysis and reporting of, for example, product sales, market share, market segmentation, reimbursement analysis, and/or other measures of business performance. They work closely with other team members in Sales Operations & Information Management, helping to ensure data quality, accuracy, timely and targeted reporting, optimized database and other information systems operations, which may include regular responsibilities to support ongoing operational management of the sales force automation/customer relationship management systems and processes. They also provide the assigned group with support in customer targeting, field workforce sizing, structuring and territory alignments, sales goal modeling and allocation, sales incentive compensation plan design, and/or payment distributions and administration. Given the nature of this role, they work regularly with cross-functional customers in the

assigned business unit or functional unit, such as Franchise Sales and Marketing, as well as a host of other internal partners and stakeholders, including Market Analysis & Strategy, gCOI (Genentech's Corporate Office of Information Technology), and others.

Key Responsibilities

• Primarily responsible for managing and training on all sales operations deliverables including operations launch planning, analytics, reporting, targeting, alignments, Incentive Compensation and Sales Force Automation for their assigned brand(s)
• Partner with sales management and Field Sales Operations to define and produce analytics that support the business objectives and strategies. Provide periodic reports and detailed analysis to identify drivers behind trends and potential business opportunities
• Develop communication materials to support field sales management on business reviews and sales force tools
• Support and respond to field sales inquiries around data
• Collaborate in the management of all IC operation activities including goal allocation, goal adjustments, IC reports. Partner with Compensation Administration team to validate and process incentive payouts, assess and provide impact on issues affecting field incentive plan
• Collaborate with the Information Technology team to define business requirements and solutions for all tools and deliverables that support the field sales force
• Comply with all laws, regulations and policies that govern the conduct of GNE activities

Sr. Strategy Manager

The Sr. Strategy Manager, Strategic Pricing & Contracting develops pricing and contract strategies for the assigned segments that optimize the value of Genentech’s portfolio, which includes leading cross-functional segment strategy development teams, building effective relationships with account core teams, internal teams across MCCO (Managed Care & Customer Operations), scenario analysis/modeling for overall financial and legal viability, and ongoing pricing and contract performance assessment/analysis.

This opening would be primarily focused on leading launch preparations for octreolin, a recently in-licensed compound for the treatment of acromegaly. Acromegaly is a disease affecting 20,000 people in the US. This is a long-term condition in which there is too much growth hormone present resulting in body tissues enlarging over time, ultimately leading to various co-morbidities and a shorter lifespan. We are excited about this opportunity for Genentech as we feel that octreolin could represent a significant advance for patients with this devastating condition. The potential launch timing is Q1, 2015.

This supervisor role would oversee the Growth Franchise (Nutropin and Octreolin) and will have one or more direct reports and will also share some of the other departmental management activities with their manager, e.g., reviewing the work of other managers, developing training/development programs and initiatives for team members, preparing and delivering senior management presentations on strategic or complex issues, leading strategic projects, etc. Given the nature of this group’s work, most management and staff in this department have considerable responsibilities for regular communications, interactions, coordination and development with partners in the broader Roche organization, and communicating with, influencing, and securing approval from senior management.

• Typically manages pricing activities and contract strategy performance analysis for more complex, high-volume or high strategic value products
  • Participates in various Genentech business planning meetings and processes
• Regularly leads strategic pricing & contracting analysis and assessment for the assigned segments, franchises and products across all stages of the lifecycle
• Acts as segment subject matter expert for assigned account segments
• Works closely with Account core teams to devise appropriate strategy for decision-making, terms and negotiation.  Executes all needed analytics to influence MCCO Governance or related field leadership teams on winning strategies
• Stays abreast of macro trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Conducts or commissions market research and competitive analysis working with other internal or external partners as necessary
• Develops detailed quantitative and qualitative analyses and modeling of pricing and contracting strategies and recommendations
• Synthesizes market and business analytics in presentations and communications
•  Works with brand pricing and contracting strategy leads to align brand or overall segment strategy with account-based needs
•  Tracks and communicates all relevant pricing and contracting trends and issues in assigned segments to internal partners/stakeholders
•  Prepares internal reports and presentations and reviews with key internal partners/stakeholders; has frequent presentations to senior management
•  Identifies and recommends metrics to assess pricing and contracting strategy effectiveness for all assigned segments
•  Tracks and monitors account performance, including post-hoc analysis of account level strategy and implementation results
•  Works closely and collaboratively with a host of internal partners/stakeholders including, but not limited to operations departments to understand operational considerations and constraints related to strategies and representing this input to the core teams
•  Recommends on contract group clustering to ensure appropriate consistencies as well as provide maximum leverage, efficiencies, and effectiveness
•  May support manager in building pricing and contracting models and other tools for department-wide analysis and assessment
• Translates research, analysis and modeling into documented pricing and contracting strategies.  Works with manager to ensure integrated cross-segment consistencies and efficiencies
• Evaluates immediate-, medium- and longer-range business and financial impacts of pricing and contracting strategies
• Identifies and supports others in planning for operational and tactical requirements to support pricing and contracting strategies for existing, new, in-line and/or pipeline stage products
• Partic...

• Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
• Lead efforts to provide on-going technical support for production at internal and external contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement
• Lead and/or participate in global initiatives and cross-functional investigational and project teams
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics manufacturing network
• Support product impact and root cause assessments for process discrepancies and Quality investigations
• Travel within the Roche network and to contract manufacturing sites will be required
  

Purpose

To provide relevant, balanced, and timely evidence-based clinical information on Genentech products to managed care customers that make decision regarding drug coverage and reimbursement, .

Description

The Associate Scientist or Scientist for Managed Care Medical Communications (MCMC) is able to communicate relevant and timely clinical information on our marketed products and compounds in late development.  More specifically, this position is responsible for communicating effectively with external customers involved in evidence-based healthcare decisions including but not limited to managed care organizations, private and government health plans, third party payors, pharmacy benefit managers, specialty pharmacies, compendia publishers, guideline bodies and technology assessment entities.  The MCMC Associate Scientist/Scientist is expected to evaluate and interpret medical literature, abstract and write medical information in various response formats, conduct scientific and clinical presentations, and apply managed care concepts and knowledge to customize our services for managed care customers.  More specifically, an understanding of the comparative effectiveness research (CER) and health technology assessment (HTA) landscape is required, as well as the ability to review, assess and synthesize CER, health outcomes research and pharmacoeconomic evidence.  Medical information is prepared and communicated using many formats (response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, scientific meetings, etc.).  This position is also involved in the review of promotional marketing materials intended for the managed markets and payor environment.  The MCMC Associate Scientist/Scientist shall effectively, appropriately, and responsibly use resources to support the use and access of our marketed products.  

The MCMC Associate Scientist/Scientist may contribute to departmental efforts to develop, implement or further improve business processes and operations.  This may include non-clinical and non-product types of responsibilities and activities such as systems and technology, training, quality assurance, writing policies and procedures.  Some business travel is expected.

Candidates should have a sound understanding of legal and regulatory topics to adequately describe the basis of Medical Communications (MC) policies and practice.  He/she must work effectively with members of the MCMC/MC staff and other internal customers that include but are not limited to: Medical Directors, Health Economics and Outcomes Research, Managed Care Liaisons, Project and Execution Managers, Regulatory, Legal, Managed Care Marketing, Field Managed Care, Medical Science Liaisons, Sales, Marketing, Access Solutions Reimbursement, and Corporate Partners.  This position shall partner with these entities to meet the information needs of managed care customers, contribute to corporate wide goals, and support the safe and effective use of Genentech products.

  Manages the implementation of Medical Data Review, both processes and application of the tools by Clinical Scientists, by providing on-site training, development of best practices, and dedicated support.  The person in this position optimizes the implementation of Medical Data Review by being an integral member of the MDR support network.

Main Responsibilities:

Provides training for medical data review tools

• Owns the scheduled training program and ad hoc on-the-job training
• Provides class room training/ one on one training as required
• Assists with the access process to medical data review tools and provides guidance
• Ensures tool users understand the data source(s) used for report generation, and assists with identification of questionable or discrepant content (includes some UAT)
• Contributes to the co-ownership of the standard training materials for MDR tools (e.g. J-Review)
• Co-develops applied job aids to support end users in use of the tools (e.g. tips and tricks sheets)
• Maintains real-time training attendance records
• Updates materials as systems undergo changes and alerts end users of changes as they occur

Provides support for medical data review

• Acts as a main point of contact for Clinical Scientists with questions on Medical Data Review processes and documentation
• Acts as the main point of contact for CDM report developers and Informatics (e.g. for specification set up and UAT)
• Acts as a main point of contact for teams engaging with CROs for MDR of external data and champions the standards used with vendors
• Provides guidance and actually develops ad hoc report objects to support ongoing MDR
• Actively solicits input from users to identify areas requiring additional support

• Delivers desk-side first level system support to end users, and understands when resolution requires escalation

• Participates in meetings with tools’ owners to ensure end users requirements are met
• Co-maintains an on-line PDC communication/document repository

Tracks system compliance

• Monitors tracking reports for tool compliance and performance of reports
• Reviews and provides the Informatics team with regular updates on status and metrics using standard/automated reports

Provides input into the global development of best practice for MDR

• Promotes knowledge sharing across the Function and within Therapeutic Areas to improve MDR best practice
• Provides input into the development of best practices of MDR Tool use and advises on the optimal use of standard tools and templates
• Proactively gathers change requests for new/different report objects or changes in processes or standard templates
• Supports the set up and maintenance of report objects built per study for medical data review
• Encourages and champions standard report objects wherever possible (cross program/TA)
• Proactively incorporates learning and recommendations from users
• Contributes to activities for improving and maintaining the quality and effectiveness of tools within Clinical Science.
• Participates in local and/or global initiatives that focus on the tools
• Makes recommendations for improvements to Informatics and Developers
• Partners with end users in proposing creation/revision of report objects
• Uses Informatics, Developers of tools for information and knowledge based resource
• Shares information across the MDR Specialist team and MDR Network
• Maintains oversight of external available tools and functionality

System support management

• Reviews and approves relevant System Development Life Cycle documents
• Contributes to future upgrades and assessment for improvements, new releases, replacement software
• Provides proactive support in terms of communication regarding updates and best practice

• Provide QA oversight, support and execution of validation/qualification activities pertaining to Investigational Medicinal Products (IMP, a.k.a. clinical) GMP manufacturing equipment and analytical instruments, including preventive maintenance and requalification activities.
• Provide technical review and approve quality risk management and validation/ qualification deliverables for small molecules and biologics equipment qualification, ensuring proper design and execution.
• Ensure that equipment and systems remain in a validated state, and that validation master plans and their related documents are accurate and current.
• Develop strategies and act as project manager for new projects in collaboration with system owners.
• Develop near-term and long-range plans for the department in collaboration with Senior Management.
• Provide technical assessment and approval for GMP changes.
• Assess equipment-related discrepancies and provide input to investigations.
• Apply expertise of compliance requirements to maintain an inspection-ready state.
• Participate in audit/inspections as a subject matter expert.
• Support implementation and provide stakeholder feedback and input to the integrated Pharmaceutical Quality System (PQS) documents.
• Perform tasks and work to achieve company goals and organizational objectives.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Provide guidance to internal and external customers on best practices for generating and executing validation protocols.
• Provide input into investigations involving GMP related failures.
• Develop and implement process and system improvements, including contributing to the development of new concepts, techniques and standards.
• Advise other IMP QEV staff members on Validation related processes and projects.
• Supervise/oversee temporary or contract staff, as required.

The Senior Finance Business Partner will support senior leaders in Technical Regulatory and Quality and Compliance (RQC).  Quality & Compliance, the broadest Functional Unit of the PT network, spans the Biologics, Small Molecule and Contract Manufacturing Operating Units.  As a business partner, you will contribute a business perspective as a member of the leadership teams and drive the planning, reporting and ad hoc financial analyses to support each of these leaders and their teams.  This position is focused on global controlling but has significant local controlling responsibilities, too.  The successful candidate will be seen by his/her business partners as a thought leader in financial issues and a “go to” person for financial / business advice. 

This position, based in South San Francisco, will report to the Head of Finance, Quality & Compliance and Technical Regulatory, located in Basel, Switzerland.

MAJOR RESPONSIBLITIES 
• As a contributing member of numerous leadership teams, provide business partner support to South San Francisco based Technical Regulatory and Quality & Compliance leaders and their respective global leadership teams. 
• Partner with RQC leadership to understand and seek new business drivers and key operational issues; actively identify tactical and strategic opportunities; contribute to the development of appropriate financial and performance metrics; recommend decision frameworks and present to senior management.
• Lead RQC global functions’ planning and forecasting exercises.
• Provide accurate and timely monthly management reporting.
• Provide decision-support analysis to management on projects and initiatives.  Leverage technical financial knowledge and available data to ensure analyses are well founded and thorough.
• Develop logic, models and presentation material for demonstrating/communicating value proposition for services provided by Regulatory, Quality & Compliance evaluating business need and significant changes within PT and Roche.
• Work closely with Accounting and Global FMT resources to ensure that RQC global functions’ financial and accounting data are accurate and aligned with principles governing technical operations including GAAP and IFRS (FGAR).
• Work with Capital Planning to ensure RQC needs are communicated and included in the Capital budget, forecast and business plan exercises.

Supervisor

• Manages the daily workflow, ensuring adequate coverage is available
  on a daily basis
• Performs ongoing analysis of existing operations and implements new functions and tactics as required
• Identifies trends/obstacles for distributor/vendor relationships and
  reimbursement activities
• Keeps current with applicable laws, regulations and policies that
  govern the conduct of activities and ensures staff members are
  adhering to these guidelines
• Maintains timely and effective communications with management
  regarding departmental issues
• Investigates and responds to customer complaints while concurrently
  instituting necessary improvements to avoid recurrence
• Ensures accountability for project timelines and SMART goals
• Provides staff with clear expectations, consistent direction, coaching and feedback
• Provides first line of support for escalated calls and external
  customer support issues
• Provides managerial support internally and externally
• Sets performance standards and conducts staff performance evaluations
• Identifies and communicates vision and strategy to team
• Identifies internal and external training requirements
• Works with internal business partners/stakeholders to understand
  their strategies and goals for integration into departmental goals and
  objectives
• Works with Planning Ops as appropriate to develop departmental budgets
• Creates, disseminates and directly manages special projects, audits
  and reports for team
• Identifies and undertakes a variety of special projects aimed at
  increasing effectiveness and finding efficiencies; also participates
  on cross-functional teams that help further operational success
• This position may require some travel and flexibility in work shift

Main Purpose of the Position

Description:  This Site Manager will manage the Production oversight related to sterile drug products manufactured at a Contract Manufacturing Organization (CMOs) located in Greenville, North Carolina.  This person will be a team leader on a CMO governance team to support right to operate and supply of critical biologic products, including a product launch.  

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug product (DP) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche/Genentech’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche/Genentech and the CMO as a point of contact for the contract manufacturing relationship at the Joint Management levels.

* Lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Lead the Roche/Genentech cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Participate in and/or Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche/Genentech’s DP products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche/Genentech through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including potential to serve as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche/Genentech’s DP manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management. Lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche/Genentech’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche/Genentech’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche/Genentech personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche/Genentech Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche/Genentech functional departments suppor...

Primary Purpose of Job (Job Summary)

> Build up and maintain best-in-industry global procurement risk management and business continuity management in close collaboration with GPP Head of Compliance, Sustainability & Supplier Diversity, the Roche Group Risk Advisory Team and the GPP Head of Risk Management.

> Develop risk management strategies, programs, processes, tools and systems that are in line with the Procurement Sustainability program in order to increase the resilience of suppliers involved in the supply of Roche’s medicines and diagnostics to patients and deliver value to stakeholders. 

> Manage and mitigate the risks related to Roche’s suppliers and ensure their commitment to sustainability by including sustainability and risk management into supplier relationship management.   

Principal Roles & Responsibilities/ Accountabilities – Major functions of the position

Management Roles & Responsibilities

* Lead Global Pharma Procurement Risk Management and related strategic initiatives

* Deputize Head of Sustainability, Risk Management & Compliance in Risk Mgmt related topics

* Lead the development and roll-out of sustainable procurement risk management  processes, tools, systems and programs in GPP in close collaboration with Group Risk Management and with category, regional and site procurement heads

* Lead the global risk management governance in GPP, including compliance with GPP risk management policies, processes and training of GPP staff

* Align with Diagnostics and IT Procurement on risk management strategy and related topics

Functional Roles & Responsibilities  

* Develop GPP risk management processes, tools, metrics and systems in close collaboration with Roche Group Risk Management, category, regional and site procurement as well as other Group functions involved (e.g., Group SHE, Finance, Legal, Quality)

* Influence Roche overall global sustainability & risk management programs and contribute to DJSI submissions

* Facilitate identification, evaluation and mitigation of procurement risks in close collaboration with Group functions, category, regional and site procurement heads and the related business partners

* Develop and keep up to date training content (including e-learnings) on procurement risk management to GPP staff and collaborate with Dia, IT on this

* Facilitate joint risk assessments of Roche procurement & sourcing teams with suppliers

* Design global business continuity management for GPP including crisis management, incident response plans and war room playbooks and facilitate implementation

* Drive compliance with the GPP Risk Management policies & processes, the Roche Group Risk Management Process and risk-related Roche Group Policies & Directives

* Support the business process managers with identification, evaluation and treatment of procurement risks related to products, materials/ services and/or suppliers in close collaboration with the stakeholders

* Ensure timely communication and reporting about procurement risks with key stakeholders, including Dia & IT Procurement, business partners and external stakeholders

* Build strong network with Group Risk Officer & team, category, regional and site procurement heads and other functions involved (e.g., Group SHE, Finance, Legal, Supply Chain, Quality)

Working Relationships

Key internal interfaces:

* GPP Head Sustainability, Risk Mgmt & Compliance

* Category, Regional & Site Procurement Heads

* Roche Group Risk Officer & team

* Head of PT Integrated Risk Management & team

* Diagnostics & IT Procurement

* Group SHE, Finance, Legal

* Supply Chain, Logistics, Quality 

* Risk Managers in procurement and other functions