Job Number:
HC-03784
Date Posted:
March 25, 2026
Position Title:
Head of QA Operations (Senior Director)
Party:
N/A
Office Code:
Office/Company:
Genentech
Reports To:
Location:
Hillsboro, OR
Contact:
Salary:
$171,000 – $317,600
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
Genentech’s Hillsboro, Oregon campus—Hillsboro Innovative Therapies (HIT)—serves as a critical hub for emerging cell & gene therapy manufacturing.Leading the implementation and monitoring of manufacturing and analytical processes in compliance with GMP, ensuring a state of operational control.Bachelor’s degree in a scientific discipline (a graduate or higher-level degree strongly preferred).
Responsibilities:
• Leading the implementation and monitoring of manufacturing and analytical processes in compliance with GMP, ensuring a state of operational control.
• Overseeing deviation and CAPA management systems, ensuring comprehensive investigations, effective corrective actions, and timely resolution.
• Managing the efficient review of GMP documentation and timely lot disposition to support compliant product release for both commercial and clinical products.
• Providing leadership for QA decision-making and serving as the primary escalation point for significant quality issues across the organization.
• Establishing and monitoring Quality key performance indicators, driving continuous improvement and maintaining readiness for regulatory inspections.
• Building strong partnerships with key stakeholders, including Site Leadership, Regulatory Affairs, and Global Quality teams, to achieve strategic quality objectives.
Qualifications:
• 15+ years of progressive leadership experience in the pharmaceutical or life sciences industry, including at least 8 years of people leadership experience in highly regulated environments.
• Substantial expertise in Quality Assurance leadership, demonstrated by successful oversight of critical quality systems, including deviation management, complaint handling, CAPA, and product release processes.
• Advanced knowledge of GMP requirements and quality regulations within the pharmaceutical industry, backed by extensive experience in preparing for and successfully navigating inspections conducted by global regulatory agencies, including the FDA and EMA.
Instructions:
Email to apply
Other:
Equal opportunity employer.
