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.

...

The Network Services Operations team is responsible for project deployment and 24x7 operations support of our North America enterprise wired and wireless networks which serve over 22,000 users and are comprised of wireless access points, switches, routers, firewalls, load balancers, proxies, VPN concentrators, and optical network devices.  

We are looking for a results-driven analytical thinker with strong technical and process management skills who can provide imaginative, thorough, and practicable technical solutions to a wide range of difficult problems.  This person will work closely with our architecture and engineering teams as well as vendors to maintain 99.99% availability while successfully deploying emerging network technologies to new and existing Genentech buildings and data centers.

Candidate must have good business acumen and possess strong communication and teamwork skills.  We are looking for an individual with strong time management skills who can work autonomously making sound decisions that are consistent with organizational objectives.  You must have a proven track record for delivering excellence thus enabling us to meet the scientific demands of our biotechnology revolution in information technologies.

...

This position  may be filled at a Strategy Manager or Sr. Strategy Manager level. 
 

The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.

• Conducting detailed analysis and constructing presentations to support recommendations to senior management on specific pricing actions for new and in-line products.
• Provides a leadership perspective on GNE pipeline pricing assessments for inclusion into payer planning activities, revenue forecast development, and decision-making.
• Works with internal/external partners/stakeholders to conduct regular market research
• Evaluating macro-trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Provides business partners/stakeholders with in-depth analyses, modeling and optimal scenarios needed to determine the best contracting strategies to meet GNE objectives
• Works closely with partners in field Account Management to understand payer/channel customer needs, expectations, challenges, etc.
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

...

Your responsibilities will encompass all the activities involved in carrying out Process Development experiments with bacterial and CHO culture processes. This will include cleaning, sterilization, batching, and inoculation of bioreactors; preparing media and solutions, performing cell counts, operating harvest equipment, process and equipment troubleshooting, and experiment data recording and collection. Operate computers for process control and data entry. Partner with other shift personnel, and staff to carry out complex experiments for the development, characterization and validation of products and technologies. This job includes the improvement and creation of standard operating procedures, implementation of new technologies and equipment, participation in continuous process improvement efforts, and coordination of processes and experiments.

Skills:
The ideal candidate will display a strong focus on safety, quality, detail and results. Must be organized and capable of multitasking, have effective problem solving abilities, and demonstrated mechanical aptitude. Can proficiently perform aseptic operations with a high degree of consistency and quality. Communicates clearly, concisely and professionally in both verbal and written manners. This position requires the ability to effectively work in a team environment with diverse skills and objectives. Successful candidates must have a high level of demonstrated initiative, be self directed, exhibit flexibility in work approach, demonstrate strong follow through and accountability, and embrace positive change.

...

Position requires an experienced Human Capital Management (HCM) Technical Analyst with demonstrated work experience on multiple project and support environments.  This role will require ability to manage complex solutions in a high-pressure, fast-paced environment in close coordination with the customer.  Excellent customer orientation is critical to the role because position is face to the customer.   

Specific responsibilities include: 

• Heavy focus on end user support; Consulting related to HR system functionalities
• Collaborate with business users, end users, system architects, developers, vendors, and engineers on system solutions.  
• Day to day system administration, application monitoring and proactive issue resolution
• Analyzing and resolving IT Incident in co-ordination with Shared Service Centers (SCC) and IT partners.
• Managing standard pre-approved change requests.  Change requests will require system configuration or coordination with solution delivery team. 
• Refresher trainings (focus on usage of current functionality)
• Creating and maintaining knowledge management in close collaboration with local IT Service Desks and Employee Resource Center (HR).

...

This role will be the strategic business partner to local leaders and leadership teams within the PD client organization, influencing the overall people strategy and ensuring effective execution of HR responsibilities. The person in this role will consult, advise, coach and partner with the business on people and organizational needs – ensuring alignment with agreed Group, functional and regional/site initiatives as well as business strategy. This role also partners with local leaders to drive organizational effectiveness including change management.

RESPONSIBILITIES:

• Act as key local HR point of contact, trusted advisor, and sounding board for client LTs.
• Identify, define and implement solutions that address the needs of the business while taking into account the broader implications (e.g. Group HR strategy, other functions).
• Contribute to the business strategy. Drive the People Agenda by applying broad HR skills in the areas of organization design and development, change management, workforce planning, coaching/consultation, program/project management, facilitation and communication. Plan and implement people/organization solutions aligned to the business & Group HR strategy and goals (i.e., actively sponsoring and leading goals at LT level).
• Ensure excellent alignment and execution of established human resources policies, procedures and Group, functional, and site HR initiatives.
• Successfully execute global and local HR processes (for example, talent management, succession planning, performance management, development planning, compensation planning).
• Partner with Global/Regional HRBPs to align and execute on initiatives and Group processes (this includes providing input to and leveraging tools and templates from CoEs where appropriate).
• Identify talent issues before they affect the business. Act as a talent scout for internal talent for local and global key positions and help develop the next generation of leaders through talent management and career development. Contribute to assessment/selection for senior leaders and other critical positions.
• Determine most efficient and effective way to deliver services based on costs, ratios and appropriate Key Performance Indicators. Collaborate with service organizations.
• Ensure compliance of all HR practices within area of responsibility and with legislative and regulatory requirements, standards and other known relevant policies and guidelines.

...

Job Responsibilities:

Reporting to the manager of the Automation Systems group, the Systems Administrator is responsible for development and support of IT infrastructure and vendor application software associated with mission-critical automation systems, including the Building Automation System (BAS), Utilities Control System (UCS), Programmable Logic Controllers (PLCs), and Vendor Supplied Controllers (VSCs). Specific responsibilities will include:

• Perform GMP maintenance activities on automation systems, including monitoring, physical and logical security, backups, and change control
• Respond to system issues (including 24x7 on-call support); Troubleshoot and remediate issues
• Complete discrepancy, investigation and CAPA records as required
• Install operating system and vendor software patches and upgrades; Design and implement hardware upgrades, system expansions and enhancements
• Support site and network projects that involve system changes
• Perform periodic reviews and revalidations according to quality standards and validation protocols
• Assess and manage risks associated with system operation and use, and design and implement improvements
• Support site audits and inspections, and implement corrections as needed
• Maintain system documentation and life cycle support strategies
• Manage vendor support contracts to ensure delivery of products and services, and process renewals to ensure continuous coverage

...

Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Main Responsibilities and Accountabilities:

• Provides direction and leadership to one or more clinical operations teams
• Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
• Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
• Creates team culture and promotes team spirit.
• Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
• In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
• Oversees the development and maintenance of study specific manuals created by the GSA.
• Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
• Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
• Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans.  Communicates variances in the budget and action plan for resolution to the GSL.
• Establishes study milestones and ensures accurate tracking and reporting of study metrics. 
• Provides operational input into the development of protocol feasibility questionnaires. 
• Provides clinical operations expertise to ensure operational feasibility and delivery
• Leads the development and finalization of site feasibility questionnaires.
• Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.
• Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
• Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers.
• Oversees forecasting of clinical/non-clinical supplies
• Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL.
• Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
• Delivers the operational elements of the study plan
• Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.
• Ensures that reporting of SUSARs is established and maintained for the duration of the study.
• Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL.
• Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
• Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
• Oversees the maintenance of drug supplies and resolution of issues with input from the Pharma Technical Drug Supplies.
• Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
• Provides operational input into the development and tracking of SMT goals.
• Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
• Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
• Develops and executes appropriate site and CRO/vendor audit and quality plans.
• Identifies areas of best practice and process improvements
• Participates in Pharma Development Operations initiatives and programs as assigned.
• Maintains oversight and ensures consistency of the operational aspects across studies within a project.
• Ensures study adherence to ICH/GCP and SOPs
  

...

The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products.

 

We are seeking a Scientist in the Department of Safety Assessment to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to small molecule programs.

 

Responsibilities:

The successful candidate for Scientist will provide scientific leadership and play an active role in the process of drug development from late-stage discovery through marketed products. Working in a collaborative team environment, the Scientist/toxicologist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity. The successful candidate will design and supervise toxicology studies to support the goals of small molecule project teams, work closely with Study Monitors, Pathologists, Pharmacokineticists and Pharmaceutics to deliver high quality GLP and non-GLP in vivo study reports and, as needed, represent Genentech in meetings with regulatory authorities. Responsibilities include interdisciplinary project team membership, preparation and review of regulatory documentation, study reports and manuscripts, participation in toxicology and pharmacology initiatives, and other active cross-functional collaborations. Additional responsibilities include investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional collaborations both within and external to Genentech are desired.

...

Franchise: Rheumatology

Product:  Rituxan RA

Territory: N.Minnesota / N. Dakota

 

 

The Clinical Specialist, Franchise Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

 

Reports to: Division Manager, Franchise Sales

 

Example Duties and Responsibilities:

• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, is regularly required

 

NOTE:

This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role.  As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

...

The Principal HR Business Partner is the "local" HR business partner for the Finance and Procurement organizations based in South San Francisco and is part of the Corporate Groups HR and Employee Relations team.  This role is the strategic business partner to leaders and leadership teams within the client organizations, including one Genentech Executive Committee member.  This position will have to manage complex/matrix relationships on both a local and global level, collaborating effectively across business and HR networks/partners. 

The person in this role will consult, advise, coach and partner with the business on people and organizational needs -- ensuring alignment with agreed Group, functional and regional/site initiatives as well as business strategy.  This role also partners with leaders to drive organizational effectiveness including change management.

RESPONSIBILITIES:

• Act as key HR point of contact, trusted advisor, and sounding board for client LTs.
• Identify, define and implement solutions that address the needs of the business whilst taking into account the broader implications (e.g. Group HR strategy, other functions).
• Contribute to the business strategy. Drive the People Agenda by applying broad HR skills in the areas of organization design and development, change management, workforce planning, coaching/consultation, program/project management, facilitation and communication. Plan and implement people/organization solutions aligned to the business & Group HR strategy and goals (i.e., actively sponsoring and leading goals at LT level).
• Ensure excellent alignment and execution of established human resources policies, procedures and Group, functional, and site HR initiatives.
• Successfully execute global and local HR processes (for example, talent management, succession planning, performance management, development planning, compensation planning).
• Partner with Global/Regional HRBPs to align and execute on initiatives and Group processes (this includes providing input to and leveraging tools and templates from CoEs where appropriate).
• Identify talent issues before they affect the business. Act as a talent scout for internal talent for local and global key positions and help develop the next generation of leaders through talent management and career development. Contribute to assessment/selection for senior leaders and other critical positions.
• Determine most efficient and effective way to deliver services based on costs, ratios and appropriate Key Performance Indicators. Collaborate with service organizations.
• Ensure compliance of all HR practices within area of responsibility and with legislative and regulatory requirements, standards and other known relevant policies and guidelines.

...

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

...

We are seeking candidates for a postdoctoral fellow position in the Ashkenazi lab to study the molecular mechanisms that control apoptosis activation in response to cell stress. 

...

Responsibilities      

• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Set up stability studies for clinical products in accordance internal PQS and ICH stability guidelines. 
• Plan and prioritize new stability studies to ensure regulatory submission timelines are met.
• Review and approve time point data to ensure regulatory compliance.
• Manage inventory of all stability studies, including sample submission to partner labs and cycle counting
• Assess and approve discrepancies of clinical and pre-clinical products
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on stability, assay review and analytical methodology as appropriate
• Identify and address gaps in systems and procedures for continuous improvements.
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

...

In this position you will be responsible for managing a framework which allows you to control, administer and deploy many different packages to our Mac population.  You will be charged with managing our inventory/asset management system and responsible for local user policy enforcements, deploying packages, updates and applications, image creation and deployments.  You will be performing thorough internal testing, working with team members on quality assurance and distribute the software via System Casper to the production environment.  In addition to software packaging, this role requires a strong JSS Casper Suite software distribution foundation with the ideal candidate having experience in implementation of machine based distributions on a global scale.

• Defining desktop hardware standards and work with engineering to secure the standard corporate image.
• Implementation and design of software distribution through Jamf/Casper and support distribution points.
• Assist application owners with the planning for the certification and deployment of new or upgraded applications including assisting with the creation of install instructions and test scripts.
• Communicate and collaborate with other IT services providers especially in the supporting areas and project/portfolio managers and ensure that every affected group is communicated to and has signed-off on the stability and readiness of the application/software.
• Participate in all aspects of the application lifecycle for applications supported within the OSX workstation environment. This includes research, analysis, testing, certification, documentation and support. 
• Assist in providing 2nd and 3rd level support with any application issue once deployed.  
• Work with engineering to develop strategies for Genentech’s operations management.
• Work with engineering to design and deploy solutions to the desktop.
• Interact with vendors and functional teams in order to restore services and correct core problems. 
• Perform daily administration, configuration, application integration, functional specifications and development tasks for infrastructure technologies and services.
• Handles and tracks routine incidents and problems and develop support procedures, technical documentation and other related documentation 
• Develop best practices and deployment services for reuse across the enterprise.
• Monitor trends and use the information to suggest and develop continuous improvements to the operations of the solution.
• Work with engineering to document and optimize current infrastructure environment.
• Under limited supervision, responds to and diagnoses problems for enterprise-managed applications and systems and/or routine hardware, software, and network problems. 
• Ability to work in a virtual team atmosphere while being self-motivated with minimum direction in a fast paced environment; as an integral part of a virtual team, you will work closely with other Team members and supporting departments across the globe

It is expected and required that he/she has current knowledge of business processes and IT industry trends and developments.  He/she is expected to have excellent inter-personal and project management skills and team work experience with operations and support staff.  Have delivered and deployed a number of IT services, systems and components.  Additional experience and knowledge of Microsoft System Center Configuation Manager or JAMF Casper Suite and related infrastructure.

The person must have a minimum of 5 year’s experience working in a medium to large company performing infrastructure implementations and operations and excellent knowledge and experience working with information management disciplines such as: server, storage, security, integration and applications. 

...

The Senior Administrative Associate (SAA) position provides full and diversified administrative support to designated members of Genentech Informatics (GI).

Duties will include, but are not limited to:

• 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.

...

POSITION:

Finance Manager (G&A Finance)

Reporting to the Associate Director, G&A Finance, the Finance Manager will provide strategic and traditional finance support to the Workplace Effectiveness, EHS and Security groups within the Site Services organization.  Workplace Effectiveness includes Genentech Real Estate, Workplace Planning, and SSF Site Engineering.  The role will interface with key stakeholders within Site Services, Finance, and other areas within the Genentech/Roche organization.

JOB DESCRIPTION:

Manage and coordinate planning deliverables to meet corporate objectives and deadlines. This includes annual budget, quarterly forecasts, the 5 Year & 10 Year Business Plans 

• 
  
• Manage the month/quarter end close processes including journal entries, accruals, account reconciliations, reporting, detailed variance analysis of results
• Member of the Workplace Effectiveness Forum - provide financial and non-financial support to assist in strategic decision making
• Build and maintain effective and collaborative business partnership between the Finance team and Workplace Effectiveness stakeholders
• Proactively identify, design, and implement enhancements to existing processes
• Propose and implement innovative solutions to complex business issues through ad hoc analyses
• Effectively communicate financial information with all levels of the organization, including senior management

...

Job Summary

The Senior Statistical Programmer Analyst (Senior SPA) works with cross-functional teams in Medical Affairs and external vendors and leads the activities in the planning, design, development, implementation and management of software and data to fulfill reports and summarized information required in support of post-marketing clinical trials, registration studies, investigations and assessments of claims databases, including health economics and outcomes research projects for Genentech and Roche products. The Senior SPA also supports internal and external requests for input into relevant documentation and materials, such as manuscripts, conference posters and presentations.

Job Responsibilities:

• The Senior SPA provides expert guidance and direction regarding statistical programming design to support timely, targeted and accurate reporting and outcomes from assigned medical affairs projects.
• He/she works closely and collaboratively with internal cross-functional partners to ensure thorough representation and alignment of cross-functional programming, data and reporting needs and objectives.
• He/she expertly manages external vendor partners supporting software developments, enhancements, maintenance and reporting to ensure consistently on-time, on-target, and accurate deliverables.
• He/she provides timely, accurate and adequate responses and inputs to/into internal and external questions, medical affairs documentation and materials.
• He/she competently and independently develops, manages, and maintains software analysis data and reporting deliverables for assigned Genentech and Roche products.
• The Senior SPA provides technical solutions to a wider range of problems with higher level of complexity, independently determines and develops approach to solutions, and recommends technical and process solutions that can be used or developed to increase efficiency of project work.
• The Senior SPA also effectively represents the department, as assigned, on cross-functional projects or work teams, and also helps on-board new team members, as appropriate, and completes special projects as assigned.

...

MainPurpose of the Position:

• Lead the planning, preparation, and conduct of QualityAssurance staff performing a variety of routine and complex oversightactivities that meet cGMP regulations and Genentech standards.
• Lead DP MQA performance and development of direct reports toensure achievement of organizational and department goals and a productive environment.

JobDuties/Responsibilities:

• Coach and develop staff by providing an environment thatencourages ongoing personal and professional development.  Manage and ensure the setting of realisticgoals for staff and provide regularly scheduled feedback throughout theyear.  Ensure staff receives appropriateknowledge and skill development and growth opportunities.
• Manage and administer all aspects of people processesrelated to the employee life cycle.  Thisincludes the selection, hiring and training of personnel on company anddepartment policies, systems and processes. Manage and communicate compensation related information per companyguidelines.
• Accountable for systems to ensure anynon-compliant events occurring in Manufacturing are assessed in a timely manneran in compliance with Quality policies and Health Authority expectations.
• Accountable for systems to ensure documentationis reviewed in a timely manner and with a high level of accuracy.
• Guide staff in meeting goals by identifying and completingassignments.
• Recommend and implement improvements to Qualityoperational policies, plans and procedures.
• Manage routine department activities and complexQuality initiatives.
• Ensure activities and initiatives are completedon time and within budget.
• Maintaincapacity model to ensure appropriate resourcing of the area.
• Presentcomplex quality issues and potential solutions at site leadership teams (QRB,Quality Council, SMART)
• Monitor and control expenditures against the departmentbudget.
• Notify Senior Management of potential quality or regulatory issues thatmay impact product quality or regulatory compliance.
• Lead and participate in continuous improvementinitiatives for Roche Quality Systems.
• Sign documents foractivities as authorized and described by Roche policies, procedures and jobdescriptions.
• Be accountable forbehaviors described in Roche’s values and Leadership Competencies.
• Perform any other tasks as requested by SeniorManagement to support Quality oversight activities.

General:

• As required, serve as a Quality liaison with regulatoryagencies and external sources regarding issues impacting quality assurancemanufacturing.

Manufacturing Quality Assurance/EnvironmentalQuality Assurance:

• Represent MQA as the prime internal and external contact oncontracts and operations.
• Guide staff in supervising and integratingquality oversight into manufacturing operations.

...