• Coordinating meetings and events making travel arrangements, preparing reports and interacting with customers and vendors.
• The SAA must be able to utilize good judgment in managing calendar appointments and access to Manager’s schedules.
• The SAA will also be responsible for coordinating, assembling and packaging presentations, agendas and other meeting materials.
• The SAA will be expected to manage conference room scheduling and coordinate meetings with other Managers within GI and across the Company.
• They must be professional in demeanor and appearance, and courteous and friendly.

IT Quality is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements.  We are looking for a customer-focused, highly collaborative individual responsible hosting and supporting audits and inspections and ensuring audit corrective actions are tracked and closed in a timely manner.   The position is responsible for effective planning and management of audits and inspections with business quality and audit groups.  Further responsibilities include:

• Leads, hosts,  and supports audit management for IT for various sites for internal and external audits and inspections and provides regular updates to stakeholders and informs management of potential issues
• Prepares IT teams for audits and inspections using his/her knowledge of IT controls and auditing practices and provides training to IT staff in support of key IT controls and audit readiness procedures
• Manages the audit program in compliance with quality requirements for ICFR, FDA regulations, legal and security policies, IT controls.
• Facilitates execution of corrective actions ensuring that weaknesses identified in the IT management system are identified, recorded, prioritized and addressed appropriately.  
•   Conducts vendoraudits and internal system assessments for Informatics
• Serves as custodian for legacy IT controls, IT Narratives, Master Audit Schedule to support audit and compliance processes.
• Develops, monitors and improves processes and tools to improve the compliance of  IT systems and to facilitate joint business decision making from a cross-functional and global perspective
• Develops strong working relationships with and partners effectively with IT delivery teams and with global Business Quality, Corporate Audit, Finance and security organizations
• Maintains industry knowledge and skills in the compliance, audit, and risk management and  applies them to improve internal processes and practices

Dept: Biological Assays, Method Management and Technology, PTQBP

Job Category: Quality
Location: SSF

Department: MMTech (Method Management and Technology)
Description: Senior Scientist Bioassay

Summary

The Biological Assay Function within Genentech’s Global Quality Organization is responsible for life-cycle management and innovation of post-BLA biological potency methods and specifications. We serve as the scientific and technical Center of Excellence for biological assays and analytical ELISAs within Commercial Quality for the Roche/Genentech Global Quality Network. We are looking for an experienced Senior Scientist to take on a leadership role and to play an integral part in the function.

 
Requirements

Candidates must have in-depth experience in the development of cell-based potency assays and immunoassays in an industrial setting. Understanding of mechanism-of-action of antibody-based protein therapeutics is essential. Broad experience with a variety of biological in-vitro systems is required. Familiarity with antibody effector function determination and enzymatic assays would be an asset. Prior experience in assay validation/ qualification and technology transfer are highly desirable, as is GMP experience and a strong sense for compliance. Familiarity with common applications analyzing the dose-response relationship will be very helpful (SoftMaxPro, XLFit, PLA etc). Working knowledge of statistical approaches will be helpful. Must be highly motivated and comfortable working independently in a fast-paced environment. Experience with regulatory submissions (IND/BLA) and Health Authority interactions will be advantageous. Management experience of direct reports is expected.

The Business Solution Manager (BSM) position is part of a global team that supports Product Development Biometrics & Clinical Operations. This role includes working on major cross-functional system initiatives, providing user support, system upgrades/enhancements, and business case development as well as integrating business processes and technology. 

In this role the BSM proactively assesses upcoming changes in Statistical Analysis tools and internal business environments, in compliance with the IT standards/processes and identifies solutions in support of the following areas:

• Epidemiology and Patient Reported Outcomes (EpiPRO)
• Clinical and Non-Clinical Biostatistics (PD, gRED and pRED)
• Thesaurus Management and Coding 

The BSM will also support cross functional initiatives led by other business areas and provide process expertise to support the development of solutions that align with the Product Development Information Landscape & Biometrics Information Landscape roadmaps.

In partnership with Biometrics & Clinical Operations, Project Management and Delivery Services, the BSM responsibilities include but are not limited to:

• Development of Roche's Informatics Biometrics & Clinical Operations IT project portfolio in partnership with the customer, project manager and solution architect. 
• Drive harmonization of processes and practices across sites and departments through common standardized data models, applications and technologies that are in line with Roche's strategies and architectures. 
• Providing efficient and effective business processes and practices expertise in a global regulated environment 
• Development of strategies to enable existing Informatics systems to address changing Roche policies and directives. 
• Knowledge of analytical software like SAS and R, especially related to analysis of ‘Real World Data’
• Participating in Roche BSM Forum and collaborate with other BSM's  
• Actively participating in industry groups to understand the future of ‘Real World Data’ and strategy to incorporate in Roche's strategies and solutions.

The PD Clinical Operations / Biometrics / Clinical Science Informatics team (part of FPPO) is looking for a senior Business System Analyst (BSA), with in depth Business analysis experience in the Pharma/Biotech industry and the ability to strategize, recommend and implement solutions with an end-to-end process filter that will meet the short and long term needs of Clinical Operations.

The senior BSA is responsible for exploring, scoping, planning and supporting the successful implementation of solutions by providing business analysis, best practice research, detailed requirements definition and user acceptance facilitation.

We are looking for an individual with strong customer focus, experience in working in global, multi-cultural environments, with a structured working approach and excellent analytical and communication skills. 

FURTHER RESPONSIBILITIES / DUTIES ARE:

• Participate and conduct strategic / exploratory workshops to identify / plan / execute innovation experiments and to contribute to robust roadmaps supporting the business strategy. Example: resource may participate to the Trial2Patients initiative 
• Collaborate with business and informatics stakeholders to lead business case development for new initiatives as well as business case tracking for completed initiatives.
• Plan early stage project efforts; specifically, requirements gathering, assessment and scoping, and project initiation and funding.
• Plan and facilitate workshops and end-user working sessions intended to surface requirements and validate designs.
• Take active role in preparing initiatives for portfolio committee and approvals at appropriate project milestones.  
• Collaborate with other BSMs / BSAs across functions and regions to identify and address business problems and opportunities, evaluate alternative informatics technologies and research industry best practices and emerging trends.
• Collaborate with Project Managers, Architects, Engineers, Developers, and Designers on scope, solutions, constraints, and risks
• Analyze document current and future business process models
• Take responsibility in ensuring the solution meets the customer needs. Support operational services teams in ensuring continued business value realization and business adoption.
• Collaborate with BSMs / BSAs within function and across functions to continuously harmonize and further develop skills and working practices specific to the BSM/BSA community within the organization 

The Senior Clinical Coordinator, Franchise Sales bringsclinical knowledge and expertise to the assigned franchise sales team.  The Senior Clinical Coordinator helpsclinical specialists and their customers increase their knowledge andunderstanding of the assigned GNE brand(s); their benefits and use as thesepertain to the relevant therapeutic area/disease state and approvedindication(s).

Reports to: Clinical Coordinator Field Manager

Example Duties andResponsibilities:

*Participates in territory/division/regional businessplanning

*Recommends opportunities to increase account knowledge ofGNE brand(s)

*May provide input into marketing materials

*Actively participates in local clinician groups

*Provides training and education sessions regarding GNEbrand(s) and their approved indication(s). Uses approved training/education materials

*Supports clinical specialists in other ways/means byattending periodic account meetings; helping to further increase accountknowledge of GNE brand(s)

*Complies with all laws, regulations and policies thatgovern the conduct of GNE activities

  The Product Quality – Biologics group is part of IMP QA.  The department is responsible for the product quality for biologics and antibody-drug-conjugates in the global Roche network throughout the development lifecycle to commercialization.  As a member of the IMP Product Quality group, the Sr. Quality Product Leader serves as the single point of contact on the technical development teams and is accountable for driving the quality activities for the teams.  This position must effectively communicate timelines and issues to Quality to ensure successful manufacturing, product testing/release and regulatory filings.    Additionally the position must partner with other organizations throughout Roche Global Pharma Technical Operations, including but not limited to: QA Operations, Commercial Quality, External Quality, Pharma Technical Development (PTD), and Regulatory (PTR).  This position will primarily support project activities during late stage development and the process handover from development to commercial as part of new product commercialization.

Responsibilities
•Participate in regular technical development team meetings and provide clear and timely feedback to the teams.•Communicate timelines and issues to all relevant Quality departments in a timely manner.
•Engage and collaborate with partner groups (e.g., within and outside Quality, external partners, etc.) and across global sites in the Roche network to ensure production, testing and release, and regulatory submission timelines are achieved without compromising product quality. 
•Proactively work with technical development teams, commercial counterparts, and senior management to identify and escalate project quality risks with the goal of delivering a robust process appropriate for commercial filing acceptable to Health Authorities and provides reliable products after launch
•Provide high level oversight of PC/PV, method validation and transfer activities during commercial filing preparation, and ensure timely escalation of timeline bottlenecks to senior management
•Lead Quality investigations, including developing proposals for resolution of product-impacting Quality issues and presentation for endorsement to Quality Review Boards, and oversight of outcome of appropriate CAPA’s associated with product-impacting investigations.

The Senior Corporate Counsel or Assistant General Counsel (Specialist) will work as part of the Healthcare Law Group within Genentech's Legal department. 
The position will have the opportunity to provide legal advice and support across the lifecycle of Genentech's products, including commercial, medical affairs, development and manufacturing functions.  Supported teams include brand sales and marketing teams, commercial strategic and operational functions, and medical affairs and development teams that have human medicines and companion diagnostics in all phases of development, and manufacturing.  Specific activities may include the following:

The Country Study Manager (CSM) provides leadership to one or more Study Management Teams (SMTs) and provides strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the US Medical Affairs portion of a study and ensures the effective and efficient delivery of the operational aspects in accordance with the medical plan and ICH/GCP standards, Roche SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers.

Responsibilities:

- Provides Direction and Leadership to one or more SMTs

- Establishes Study Timelines, Budget, Resource, Risk and Quality Plans

- Manages the Delivery of Study Activities in Order to Meet Study Plans

- Builds effective, high performing SMTs through influence, integration, motivation and optimization of team performance.

- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, eg, Pharma Business

- Functions as Study Management Team Leader.

- Maintains awareness of external clinical research practices to ensure the SMTs are aware of the risks, priorities, value and impact of their work and contributions.

- Provides input into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures.

- In accordance with the overall medical plan, establishes and maintains accurate study level plans in designated resourcing and planning system.

- Is accountable for the development and active management of the study patient recruitment strategies in US Medical Affairs.

- Develops Partnership with Business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.

- Is accountable for the selection, training and direct management of external suppliers supporting US Medical Affairs trials.

- Ensures that data is delivered in accordance with established dataflow timelines.

- Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in Investigator Meetings as necessary.

- Monitors progress against SMT goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.

- Oversees the management of the Clinical Operations studies budget.

- Leads the evaluation of standards across one or more SMT(s) with the objective of enhancing quality, productivity and efficiency. 

Senior Director, Contracts Process and Operations 

Location:  San Francisco

* This leadership role is responsible for leading a team of leaders in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and is accountable  as the global contracts business process owner to ensure optimal GPP value delivery to our business partners.   

* This leader will be leading an organization that is bringing together all GPP contracts teams into one function to leverage best practices and align with the GPP Go Simple project to streamline contracting processes within GPP.  

* This leader has strategic accountability for activities associated with development and execution of contract agreements for all GPP customer groups globally (Product Development, Research, Technical Operations, Global Product Strategy, US Commercial and US Site Services) 

* This leader is the primary liaison with senior leaders in various GPP client groups and US/EU legal organizations and must be able to effectively influence senior leaders

* Accountable for appropriately managing legal and compliance risk on behalf of Roche in the execution of the contractual process including negotiations of terms and conditions. 

* This leader is accountable for connecting the Contracts process to solutions (IT) and service delivery.

Key Relationships

• Internal: Provides guidance and mentoring to Contracts staff members in contract development and administration and working effectively with Genentech user community and vendors

• Business Partners 

• External: Seeks out industry benchmarks

• IT and the S2P Steering Committee

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages  6 direct reports and manage a team over 110 employees and contractors.

* Responsible for developing and implementing contract processes and managing a group of professional contract staff globally representing all GPP functions.

*  Ensures that a wide variety of company contracts are negotiated and processed to meet the needs of multiple client groups.

* Manages the contract process from initial request to contract execution, focuses on agreements with complex legal and business risk.

* Actively manages the GPP Contract process and support the connection to the overall Procurement Processes of Category Management, Contracting, Request to Pay and Master Data processes. 

* Ensures all policies that govern the conduct of contracting activities are adhered to in accordance with all legal policies globally

* Works with Roche/Genentech user community to ensure there is a complete understanding of contract requirements.

* Works with direct reports, other team members, and various internal business partners to review contract service levels and performance.

* Participates in process improvement or other projects that enhance and streamline contracting processes, systems, tools and other resources; collaborates legal departments to improve contract templates and processes.

* Provides direction and training to teams regarding good business procedures and contract business terms; shares best practices and feedback on contract and budget matters to Contracts staff and  GPP teams.

* Identifies and manages areas of risk and compliance both in the establishment of contracts and in the operation of the contracts and the relationship with the outside vendor.

Genentech is currently searching for a Senior Director, Department of Immunology. The incumbent in this role will be responsible for all target and therapeutic discovery activities for autoimmune and inflammatory diseases in the Genentech Research and Early Discovery organization. The incumbent also will oversee the interactions between the Immunology Department and all diagnostic, clinical, commercial, and business development activities for these diseases.

Purpose:

The senior utilities engineer provides technical leadership and accountability for plant and GMP utilities engineering in the delivery of capital projects and engineering services for research and development (R&D) and quality laboratory, as well as commercial and clinical manufacturing related facilities.

Responsibilities:

• The senior utilities engineer will work effectively on multi-discipline engineering capital project teams, as well as other project related cross-functional teams with representatives from departments throughout the Pharmaceutical Technical Operations and R&D organizations.

• Responsibilities may extend to all regional Americas manufacturing and research facilities, as well as the network of Contract Manufacturing Organizations organized under the Manufacturing Collaborations group.

• The primary area of focus for this position will be the execution of projects from design through commissioning and qualification. The senior utilities engineer will be accountable for:

- Planning and Execution of Projects: including project approach and resource needs, options analysis, utility systems and equipment design, engineering document development, and system ownership through the project delivery phases of plan, design, procure, construct, commission and qualification for research, cGMP and development facilities; and 

- Technical Analysis:  including utility system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability.

• Areas of expertise include systems and equipment for purified water, water for injection (WFI), clean steam, process air, process gases and process waste, as well as associated knowledge in plant steam, plant chillers and utility piping.

• This position requires coordination of Genentech/ Roche and/or contract engineering resources.  Facilitating meetings, directing engineering firms and consultants, field supervision, equipment inspection and start-up, construction trade coordination, and training of operational staff are often required.  Success in these areas will depend upon the individual’s ability to effectively communicate, collaborate, and foster positive interactions with team members, while diligently managing adherence to project scope, budget and schedule.

• The senior engineer is expected to be an effective communicator of ideas, project goals and results.  With minimal supervision, is expected to make presentations and updates to senior management and in broader forums both internal and external to Genentech. 

• The senior engineer is expected to contribute to increasing the efficiency and effectiveness of the Engineering Technology department by contributing toward infrastructure improvements to guidelines, procedures, practices, standards and cross-functional business processes.  The senior engineer should share insights and improvements, participate in design reviews across the portfolio of departmental projects, and contribute to best practice forums across our network of global engineers and partners. 

The Global Engineering team is responsible for making technology happen for Genentech and Roche global by transforming the “technology roadmaps” into live solutions. The Global Engineering team is present in 4 locations: Basel, Madrid, Shanghai and South San Francisco, covering all time zones with around 100 highly qualified engineers. The Senior Engineer Security & IAM, NALA Region position is located at the South San Francisco site. The main responsibilities of the position are:

• Design and develop technology solutions, including evaluation of promising technologies and development of evaluation criteria
• Work with vendors, architecture, operations and solution owners managing the Proof of Concept and testing scenarios
• Lead multi-threaded, globally distributed and complex projects
• Mentor less experienced team members on industry standard design practices
• Perform configuration, integration, functional specifications and development tasks for technology solution and services, including first implementation of the designed solutions
• Develop best practices for technology solution for reuse across the compute environment
• Ensure efforts and solutions align and adhere to the organization’s Technical Architecture Framework (TAF) policies, standards and direction as well as Solution Owner requirements
• Ensure proper training of support teams on the technology solution
• Stay abreast of operational difficulties and issues; work with support team staff to provide escalation support. 
• Document and optimize technology solution environment as required
• Ensure Quality standards as per company specifications are followed
• Occasional travel and working outside standard office hours including weekends and holidays

• 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
  

Senior Finance Manager 

JOB DESCRIPTION:

Position is dedicated to supporting the financial management of the South San Francisco Production Business Unit (BU). The position will report to the Associate Director of Finance for South San Francisco Production and is part of the Technical Operations Finance group, which is charged with the financial stewardship of Genentech's Technical Operations organization.

MAJOR RESPONSIBLITIES

Responsible for the financial planning, analysis, and reporting activities of the South San Francisco Drug Product Manufacturing operation. Act as point of contact between the operating group and the finance organization. 

Financial Management & Controls

• Perform month-end close activities, including monthly production activity, cost allocations and reconciliation of inventory balances. Identify, investigate, and resolve potential issues within tight time constraints. 
• Manage and control expense and capital transactions through the corporate accounting system (SAP BW) including maintaining and reconciling accrual transactions. 
• Communicate effectively with internal finance departments, including Vendor Finance, R&D Finance, Capital Finance, Corporate FP&A and others to ensure quick and accurate resolution to financial issues.
• Support and direct Internal Control audits.
• Actively participate in development of new business systems and metrics, working with the Technical Operations Finance and Corporate Accounting organizations as necessary to define and implement. 

Planning and Analysis

• Work with operations teams to provide input on the development and tracking of appropriate metrics and goals for planning horizon. 
• Lead business partners in the execution of planning exercises (forecasts, budgets, long-range plans): 
• Coordinate efforts of business partners to prepare operating expense, headcount, and capital forecasts so that all submission requirements and all deadlines are met. 
• Analyze budget forecast proposals for strategic consistency and suggest modifications as appropriate. 
• Provide support for all presentations and submissions. 
• Identify and execute opportunities to improve operational results. Partner with Business Unit management to achieve targeted costs and continuously improve.
• Analyze spending and cost of production monthly and provide direction to BU management using SAP. 
• Develop financial decision frameworks for operational issues and lead analysis through final recommendation. 

Reporting

• Perform efficient and pertinent month-end reporting, including investigation of spending and manufacturing variances. 
• Prepare and present monthly financial results to site and financial leadership.
• Use financial reporting to direct BU management toward areas of improvement or to surface operational issues.
• Prepare and present quarterly capital spending updates to site and Technical Operations leadership. 
• Support Site Capital Governance Team in Capital Reporting, Planning and Financial Analysis. 

MAJOR SKILLS TRAITS:

• Demonstrated analytical acumen and problem-solving skills.
• Independent self-starter and proactive leader. Seeks to continually improve business processes. 
• Strong communication and presentation skills and demonstrated success building partnerships across organizational boundaries (within a manufacturing environment desired). 
• Commitment to customer service with a strong sense of ownership for projects and results. 
• Must be able to work in a fast-paced environment that often requires commitment of more than 40 hours week.

Purpose:
The Senior Financial Analyst position resides within the Commercial Finance Operations group and plays a key role in the direct support of the Commercial brand teams’ product marketing activities. The Senior Financial Analyst (SFA) supports the brand teams by: (i) driving month-end close activities through reviewing expense accruals/prepays (ii) financial review of new SOWs/ contracts and purchase requisition/PO set-up (iii) supporting the Commercial planning processes i.e. forecasts updates and tactical plans (v) financial performance reporting and variance analysis (vi) actively leads/participates in process improvement projects within the Commercial Finance Operations team. 

Responsibilities:
Directly support multiple/complex brand teams’ marketing activities, meet with stakeholders on a regular basis to gain budget allocation and financial spend input, and to provide regular updates on the status of spend as compared to product marketing budgets and forecasts.
¿ Prepare monthly financial reports and variance analysis comparing actuals to latest forecast (or latest Basel forecast) and budget, and provide insight into remaining forecasted spend and other ad hoc analysis to understand trends of their direct product marketing activities.
¿ Take on other brand/functional P&L responsibilities to further develop knowledge of the business.
¿ Ensure contract policies and processes are followed in a timely and compliant manner focusing on the financial review of vendor agreements and statements of work (SOWs).
¿ Support Commercial Finance’s ICFR assessment by reviewing / researching the list of out-of-compliance transactions and ensuring that material product marketing arrangements with vendors are covered by purchase orders or other approved contracts and are accrued as appropriate in the financial statements.
¿ Identify areas of inefficiency and ineffectiveness and lead projects that improve Commercial financial processes; partner with colleagues, customers and Commercial Finance to assess and implement recommendations in a timely and effective manner.
¿ Proactively and accurately communicate on a regular basis with partners in Commercial Finance (Finance Managers and Leads), brand teams, other Commercial organizations, corporate departments (e.g. Legal and Finance) and external vendors.
¿ Identify and articulate improvement initiatives aligned with group and departmental goals and actively lead and/or participate in process improvement projects, as required.
¿ Serve as a subject matter expert on Commercial finance processes, leveraging in-depth knowledge of Commercial and cross-functional systems, including SAP, T2E and TM1.
¿ Take on the “buddy” role to onboard/train new hires and acclimate them to the commercial funding, contract logistics, budget tracking, purchase order set-up, accrual and forecasting processes and related accounting policies and procedures.