ProvideQA oversight, support, and execution of validation/qualification activitiespertaining to Investigational Medicinal Products (IMP, a.k.a. clinical) GMPmanufacturing equipment and analytical instruments, including cleaningvalidation and computer system validation, related to IMP operations.
QAoversight and support of IMP GMP facilities, preventive maintenance, andrequalification activities pertaining to IMP analytical testing laboratory andmanufacturing production equipment.
Provideassessment and oversight of validation/qualification activities at ContractManufacturing Organizations (CMO).
Approvequality risk management and validation/ qualification deliverables for GMPsmall molecule, biologic, and device/combination product systems (facilities,utilities, and equipment); laboratory systems; computerized systems; andpackaging and shipping systems, ensuring proper design and execution.
Ensurethat equipment and systems remain in a validated state, and that validationmaster plans and their related documents are accurate and current.
Develop strategies and act as projectmanager for large projects in collaboration with system owners.
Develop near-term and long-range plansfor the department in collaboration with Senior Management.
Provide technical assessment andapproval for GMP changes.
Assessequipment and facility-related discrepancies.
Lead investigations involving GMPrelated failures.
Applyexpertise of compliance requirements to maintain an inspection-ready state.
Participatein audit/inspections as a subject matter expert or program manager.
Supportimplementation and provide stakeholder feedback and input to the integrated PharmaceuticalQuality System (PQS) documents. Whereapplicable, act as part of the authoring community to develop and improve PQSdocuments.
Performtasks and work to achieve company goals and organizational objectives.
Serve as the Quality representativeon cross-functional and multi-site teams.
Develop solutions to complex qualityengineering and validation issues.Solves complex problems independently.
Develop and implement process andsystem improvements, including contributing to the development of new concepts,techniques and standards.
Advise other IMP QEV staff memberson Validation related processes and projects.
Supervise/oversee temporary orcontract staff, as required.
Who You Are
B.A., B.S., M.S., Ph.D.degree (preferably in Life Science or Engineering) and at least 8 yearsexperience in the pharmaceutical, biopharmaceutical or related industry, or anequivalent combination of education and experience
Experience with analyticallaboratory equipment, manufacturing production equipment, cleaning validation,and data integrity (preferred)
Sound knowledge of localand global cGMP requirements as well as internal PQS requirements
Strong background inQuality Systems and Validation supporting both Biologics and Small Molecules(preferred).
Independently work withminimal supervision.
Ability to make sounddecisions about scheduling, allocation of resources, and managing priorities
Abilityto communicate clearly and professionally both in writing and verbally.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.