This position is for Swing shift (Monday – Friday 2:00pm – 10:30pm).

Main Purpose of the Position:   

• Solve a variety of routine and difficult Manufacturing Quality Assurance and product release issues following cGMP regulations and Genentech standards       
• Perform assigned tasks and work to achieve company goals and department objectives. 

Job Duties/Responsibilities:

·               Follow company policies and procedures.

·               Maintain a state of inspection readiness.

·               Provide input to the development of personal performance goals and departmental objectives.

·               Collaborate with Management to establish and meet targets and timelines.

·               Independently manage competing priorities with limited instruction.

·               Serve as a Quality representative on cross-functional and multi-site teams.

·               Identify and recommend solutions to potential procedure, process and system gaps.

·               Provide assistance to customers in support of departmental functions.

·               Participate in the design and implementation of department and cross-functional initiatives.

·               Apply basic theory and technical principles to address moderately complex problems.     

·               Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

·               Serve as a technical subject matter expert (SME) in support of department functions.

·               Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.       

·               Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

·               Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:

·               Evaluate and close complex, non-investigational discrepancies.       

·               Initiate discrepancy investigations as required.       

·               Draft and route discrepancy summaries to Discrepancy Management.         

·               Perform Assessor and Evaluation activities defined in the Discrepancy Management System (DM...

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Directors provide regulatory leadership for one or more regional or global development projects. Regulatory Program Management Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Directors are expected to lead more complex projects and represent PDR to cross-functional teams and groups with increased independence. Regulatory Program Management Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners.  Regulatory Program Management Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

DUTIES & RESPONSIBILITIES:

• Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Provides regulatory expertise and leadership to site, regional or global cross-functional teams and other groups
• Stays abreast of therapeutic area product development and other related business strategies and plans 
• Serves as the primary PDR representative on one or more regional or global projects at any one point in time; typically complex projects
• Analyzes data, the regulatory environment and business objectives to recommend priorities
• Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche
• Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
• Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
• Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
• Serves as the site, regional or global principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site, regional and/or global teams
• Provides internal teams with direction on regulatory authority interactions
• Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources
• Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
• Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 
• Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
• Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and meet...

The Manager / Senior Manager will support the late stage PPP team as itdelivers on a range of projects in support the late stage oncology portfolio.  Key activities forwhich PPP is responsible include:

• Portfolio Management and Reporting
• LifeCycle Team, Planning, Governance and Decision Support
• Strategic Projects at the TA Level and Cross-Portfolio
• Governance / Support for Late Stage Portfolio Committee

The role requires ability to providestrategic, analytical and systems support to late stage teams, TA heads, andother stakeholders in the Roche organization.

Responsibilities

Representative responsibilities associatedwith the role are detailed below:

• Portfolio Management and Reporting
• Participate on multiple lifecycle teams and ensure that portfolio reflects ongoing investments in programs
• Prepare quarterly reports on progress of portfolio and implications (incl. strategic context) for senior managers
• LifeCycle Team, Planning, Governance and Decision Support
• Consult with lifecycle teams to provide decision analysis and other analytic and strategic support
• Support development of business cases for all investments/changes, including valuations
• Facilitate annual prioritization, goal setting, lifecycle planning and business planning processes
• Advise teams on internal governance processes associated with changes/new investments
• Strategic Projects at the TA Level and Cross-Portfolio
• Support development of molecule, pathway and disease area strategies
• Frame portfolio issues and conduct gap analyses to enable management to make informed and timely decisions, including corporate goal setting and portfolio optimization
• Facilitate TA level opportunity prioritization and strategic context
• Support partnering opportunities at the TA level
• Governance / Support for Late Stage Portfolio Committee
• Work with development teams to ensure that decisions go through appropriate governance
• Advise teams and stakeholders to ensure decisions are aligned with portfolio priorities

Job Skills and Expectations

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.

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).

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.

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. 

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.

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.

The Informaticsteam is looking for a highly skilled Operations Lead, who will support the systemsthat enable the Sales & Marketing business teams.  In this role you will work closely with thebusiness leads, end user community, development teams, vendors and serviceproviders to provide the overall IT service. As service lead, the individual may also play other roles as requiredlike project manager and business analyst to ensure optimal service delivery.  This candidate will be proactive, outgoing and detail-orientedwith excellent problem solving and written/verbal communication skills.  The Operations Lead will have excellentcustomer relationship management skills with a service minded attitude and abilityto translate informatics terminology into business relevant language

Further responsibilities are:

• Supports day-to-day operations and / or implementation of projects within area of technical expertise, contributes to and executes implementation plans
• Manages incident and problem management processes as well as release and configuration management.  This includes continuous improvement for the management of the services.
• Acts as the initial point of escalation for incident, problem and change management for the business leads
• Administers change control procedure and processes. This includes the management of the change control board and oversight of approved changes
• Is well versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships
• Applies complex procedures and defined standards to meet business, customer and technical requirements and leads others in resolution of complex problems
• Leads specialist resources on technical issues within the domain and provides detailed analysis of the operations and opportunities for improvement
• Develops business/technical critical know-how within area of expertise.  Assists in the development of others know-how by passing on knowledge of tools and techniques
• Accountable for rollout of new services and enhancements to existing services
• Familiar with Statement of Work (SOW) and procurement processes
• Tracks problems/issues to resolution with the appropriate level of follow-up with the user community
• Participate in project teams to help identify solutions and requirements for new functionalities and performing impact analysis
• Builds and maintains good working relationships with the business leads and the user base, monitors services and provides regular service reports to Informatics and business leads

Group Strategy Manager 

 
The  purpose of the Group Manager, Strategic Pricing & Contracting role is to oversee and/or develop pricing and contract strategies for the assigned therapeutic areas and/or customer segments that optimize the value of Genentech's portfolio, which includes leading cross-functional strategy development teams, building effective relationships across all franchises relevant to the assigned therapeutic areas and/or customer segments and scenario analysis/modeling for overall financial and legal viability, as well as ongoing pricing and contract performance assessment/analysis.

1. Act as a lead subject matter expert from Strategic Pricing & Contracting
2. Play the lead role in cross-franchise assessment and integration of pricing and contracting strategies, plans and tactics; includes providing a leadership perspective and strategic pricing and contracting inputs into all business plans relevant to the assigned therapeutic areas and/or customer segments
3. Provide a leadership perspective on Genentech pipeline developments, as these relate to pricing and contracting strategies development and strategic options
4. Work effectively with Genentech executives to transfer and leverage learning across brands
5. Act as the lead contact on all internal and external communication regarding pricing and contracting strategies, philosophies and practices for the assigned therapeutic areas and/or customer segments; includes responding to internal/external inquiries regarding Genentech's pricing and contracting philosophies and practices
6. Develop internal/external reports, presentations and training to educate others in Genentech's pricing and contracting philosophies and practices
7. Take a leadership role in training other team members and internal partners/stakeholders in pricing and negotiating theory/application
8. Support manager in longer-range departmental planning; determining resource requirements, headcount, infrastructure, systems, tools and the like
9. Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies

The primary mission of the Genentech Research & Early Development (gRED) organization is to discover and rigorously assess promising molecule candidates for viable therapeutic benefits. Within the Early Development segment, the Clinical Operations department is responsible for “first in human” Clinical Trials to assess the benefit and risks of a given therapeutic treatment and is embarking on a 3-year technology program to advance their organizational processes and capabilities.

As the gRED IT Tech Lead, your primary responsibilities are to provide modern technical solutions for the complex business needs in Clinical Operations, to contribute and coordinate IT project work and to support the operational technology landscape within the IT organization. You are a great team player, and self-driven individual who works well with other IT professionals towards the common vision of delivering information systems to enable the company to continue providing novel therapeutics for our patients.

Responsibilities:

• To design, develop, test and implement solutions based on customer requirements with an innovative approach.
• Able to work with customers to gather project requirements and can translate them into a functional solution.
• Provides architectural and engineering input in technical aspects of business planning such as program, project or roadmap planning. Collaborate with Global Architects as required.
• Provides deep technical expertise over a broad set of current technologies and mentoring of other team members in these areas. 
• Within project teams, collects and defines requirements, designs, develops, tests and documents final solutions according to Genentech's project management methodology
• Works with validation teams to ensure GxP validated solutions comply with FDA regulations throughout the solution lifecycle.
• In an operational setting, manages the deployment of software enhancements, troubleshoots production systems, contributes to root cause analyses and adheres to customer SLAs all while providing excellent customer service
• Works with a variety of in-house developed, commercial off-the-shelf (COTS) and SaaS software, across the globe, that provide organizational capabilities to manage Clinical Trials
• Experienced with web programming languages such as HTML, CSS, XML, PHP, Python, Perl and Java on Linux and Windows varieties.
• Experience with Business Intelligence and data warehousing solutions including Oracle databases, Informatica ETL, Business Objects and  Roambi mobile reports.
• Experience with Enterprise solutions including Google Apps, Livelink, Sharepoint, Jive SBS and iOS mobile applications.
• Collaborates with internal and external business partners and can lead contractors and vendors in design, development and testing activities.

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

The Position:

The Senior Manager of Employee Giving & Volunteerism

The Senior Manager for Corporate and Employee Giving will create an integrated strategy for sponsorships and service and establish an overall volunteerism approach that better engages our approximately 12,000 employees and meets emerging business needs.  The Senior Manager will interact closely with senior leaders from across Genentech to support the company as a great place to work.

RESPONSIBILITIES:

Apply deep subject matter expertise to establish customized service & volunteerism practices that address business challenges including recruitment, retention and skills development as well as enhancing corporate reputation and general employee engagement.

Drive a cross-functional effort to identify strengths, assess gaps and offer solutions that are unique to Genentech. Ensure understanding of operational issues; actively identify strategic opportunities; recommend decision frameworks and present to senior management.

Drive Genentech’s adoption of best practice and cutting edge approaches (eg Pro Bono & skills based volunteerism);

Create and lead plan for successful implementation and socialization across all key stakeholders. Define and measure progress; develop appropriate first-of-a-kind metrics for success.

Manage support staff for volunteerism & employee giving, including outside vendors and internal contractor staff. Provide support for GNE’s employee-volunteer site-based philanthropic giving teams in Oceanside, etc.

Partner with the Principle Manager for Corporate Citizenship in strategic decision-making to support the design and potential launch of a Signature Philanthropic Giving program for Genentech.

Continue to evolve strategy and objectives to ensure ongoing value to the business

The Finance Manager will be part of a team that provides financial planning systems and reporting development, enhancement and maintenance expertise for Roche Canada finance groups and Genentech Commercial finance groups.  The position is located in the United States Eastern time zone and will report to the Finance Manager of Commercial Financial Planning Systems who is based in South San Francisco, CA.  The Finance Manager will be expected to travel to Toronto, Ontario and South San Francisco occasionally – six to eight times per year

The working environment is fast-paced with an ever-changing set of priorities.  The role will interact extensively with the following finance organizations:

• Manage Quality system for change control and document management functions for GMP changes involving equipment, documents, test methods, processes and specifications for IMP Small Molecule and Biologics operations.
• Manage workflow through Trackwise and EDMS to ensure timely release of systems and documents.
• Proactively identify, prioritize and assess quality systems compliance risks across the IMP network
• Manage Quality System for discrepancy and CAPA management for IMP customers.
• Perform routine Quality trend analysis of IMP discrepancies and audit of incident discrepancies.
• Manage workflow through Trackwise discrepancy and CAPA systems
• Manage and oversee GMP self inspection program for IMP manufacturing and testing areas including:
• Maintain plan and schedule for self inspection audits
• Coordinate self inspection audits with other subject matter experts.
• Issue audit reports and track corrective actions from audits.
• Communicate to PTDQ-U leadership regarding compliance status
• Provide Quality oversight to GMP IMP Contract Laboratories/Organizations.
• Maintain list of approved contract testing laboratories and corresponding Quality Agreements
• Provide support for establishing new Quality Agreements, revising or renewing existing Quality Agreements, and periodic review of Quality Agreements
• Participate in lab audits as needed
• Serve as the QA representative on cross-functional and multi-site teams.
• Facilitate continuous improvement and the sharing of best practices at the various IMP global sites
• Provide guidance to internal and external customers on best practices for various Quality Systems.
• Mentor and supervise (as required) other Quality System staff members on Change Control, Discrepancy, CAPA, Self-Inspection, and Quality Agreements and or related processes and projects.

We are seeking an outstanding individual for theposition of a Research Associate / Senior Research Associate within theBiochemical and Cellular Pharmacology department. The successful candidate willbe responsible for supporting research projects in the disease therapeuticareas of immunology and/or immunotherapy as part of the biologics drugdiscovery program at our South San Francisco campus. The individual will be expectedto work independently in developing and performing immunochemical, biochemical,and cell-based assays to support candidate selection, potency, efficacy, andpharmacokinetic studies as well as immunogenicity evaluation andpharmacodynamic biomarker measurements. In addition, the individual will incorporateautomation into his/her daily work and apply novel technologies in assaydevelopment.