This position is part of Genentech's Hillsboro Innovative Therapies (HIT) Quality Systems (QS) team dedicated to ensuring the highest standards of document management and control for innovative cell therapies. As an integral member of this team, you will collaborate with various inter-site and intra-site departments to maintain compliance with global Health Authority regulations and contribute to regulatory inspection readiness.
The Opportunity:This role is an integral part of our Quality Assurance (QA) team, dedicated to ensuring that both commercial and clinical pharmaceutical products meet specified requirements and regulatory standards. This position offers the opportunity to collaborate closely with key team members across Manufacturing, Regulatory, Global Quality Systems, and external partners.
- Ensure lot disposition and release of products in compliance with approved registration dossiers, internal standards, and local/international laws
- Review and approve quality documents, batch records, and other QA-controlled documentation, ensuring GMP compliance
- Provide Quality Assurance oversight throughout production operations, including Chain of Custody and Chain of Identity
- Lead and support cross-functional projects and Quality initiatives, fostering effective interdepartmental and cross-functional relations
- Manage deviations and CAPA processes, ensuring detailed investigations, effective implementation of corrective actions, and timely resolution
- Participate in and support internal and external audits, serving as a Subject Matter Expert for lot disposition practices and QA documentation
- Assist in building and managing a robust complaint management process, including oversight of complaint intake, evaluation, trending, and issue escalation
Who you Are:- You have a Bachelor's degree in a relevant scientific discipline AND at least 6 years of work experience in the pharmaceutical or related life science industry
- You have at least 6 years of experience in Quality Assurance (preferred), Quality Control, Manufacturing, MSAT or other GMP production related experience and have an expert knowledge of QA principles, practices, and standards specific to the biopharmaceutical industry
- You demonstrate the ability to work collaboratively with team members to resolve moderately complex issues and participate in cross-functional initiatives
Preferred Skills:- Experience with Advanced Therapeutic Medicinal Products (ATMP), e.g. cell therapies
- Familiarity with computer systems and ability to quickly become familiar with new software (e.g., EDMS, LIMS, SAP)
- Knowledge of GMP relevant to the pharmaceutical industry (local and international)
- Knowledge of regulations related to ATMP (Advanced Therapy Medicinal Products)
Compensation:The expected salary range for this position based on the primary location of Oregon is $75,040 - 139,360 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
BenefitsNotes:- Relocation benefits are approved for this position.
- This position is an on-site role; remote options are not available.
- The ability to work flexibly outside of normal business hours may be required to support business operations.
#LI-CA1#ptcareers#cellandgenetherapycareers#Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.