THE POSITION

This position is part of Genentech’s’ Pharma Technical - individualized and cell therapy team based in Hillsboro, Oregon. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities including building GMP-compliant processes to manufacture, test and release products in a fully GMP-compliant facility, and the quality approach for this exciting and novel technology.

QUALIFICATIONS FOR QA SPECIALIST III:

• You possess a Bachelor’s Degree (preferably in Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant discipline) AND at least 3 years of pharmaceutical or related life science industry experience
• You possess at least 3 years of experience in Quality Assurance, Quality Control, Manufacturing
• You possess knowledge of Quality Assurance principles, practices, and standards for the biopharmaceutical industry
• You have an understanding of GMP relevant to the pharmaceutical industry and knowledge of local and international GMP regulations; knowledge of regulations related to ATMP is desirable
• You possess strong verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills
• You are an effective problem-solver
• You are familiar with computer systems and aptitude to quickly become familiar with new software (e.g., EDMS, LIMS, SAP)

QUALIFICATIONS FOR SENIOR QA SPECIALIST:

• You possess a Bachelor’s Degree (preferably in Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant discipline) AND 6 or more years work experience in the pharmaceutical or related life science industry
• You possess at least 8 years of experience in Quality Assurance, Quality Control, Manufacturing
• You possess expert knowledge of Quality Assurance principles, practices, and standards for the biopharmaceutical industry
• You have an expert understanding of GMP relevant to the pharmaceutical industry and knowledge of local and international GMP regulations; knowledge of regulations related to ATMP is desirable
• You possess excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills
• You demonstrate excellent problem-solving skills, tactical strategy, and diplomacy
• You have demonstrated experience with computer systems and aptitude to quickly become familiar with new software (e.g., EDMS, LIMS, SAP)

In this role, you will be responsible for ensuring that both commercial and clinical (IMP) products meet specified requirements and are released in accordance with legal compliance and Roche quality standards. Your primary accountability will encompass reviewing and approving QA controlled documentation, including procedures and master batch records. Additionally, you will:

• Ensure lot disposition and timely release of commercial and clinical products in compliance with internal standards and local/international laws
• Create, revise, and review quality documents; provide oversight for operational procedures to maintain GMP compliance
• Lead and support cross-functional projects and Quality initiatives; resolve Quality risks through interdepartmental collaboration
• Assess and resolve deviations promptly, partnering with functional areas to investigate and address product quality impacts; manage CAPA processes effectively
• Meet budgetary goals for QA Operations and promote a positive safety culture aligned with Safety, Health and Environment requirements
• Provide Quality Assurance oversight of end-to-end production operations, including Chain of Custody and Chain of Identity
• Participate in internal and external audits as a Subject Matter Expert, ensuring readiness for inspections and defending lot disposition practices and GMP compliance
• Collaborate with Manufacturing, Site functions, PTD, Affiliate Quality Assurance Management, Regulatory (PTR), Global Quality System and Management, External Quality, Supplier Quality, suppliers, and CMOs to ensure cohesive quality standards and compliance across all operation