Genentech’s Hillsboro Oregon campus—Hillsboro Innovative Therapies (HIT)—serves as a critical hub for emerging cell & gene therapy manufacturing. Housed within a modern 75-acre facility just outside Portland, HIT is at the forefront of advancing cell and gene therapy medicines through accelerated clinical and commercial manufacturing capabilities, aligning with Genentech’s mission to bring transformative therapies to patients.
This role is a critical part of our Quality Assurance (QA) team, which plays an essential role in ensuring the delivery of high-quality commercial and clinical (IMP) products in compliance with global regulations and Roche's internal standards. As a leader within QA, you will oversee end-to-end quality processes, including batch release, deviation management, and regulatory compliance, while collaborating closely with Manufacturing, Regulatory Affairs, Global Quality, and site functions. This position offers the opportunity to drive strategic goals, foster a culture of continuous improvement, and contribute to a state of operational excellence in alignment with Good Manufacturing Practices (GMP).
The Opportunity:
As the Head of Quality Assurance Operations(Senior Director), you will ensure that commercial and clinical (IMP) products meet quality and compliance requirements while driving operational excellence and maintaining a state of readiness for regulatory inspections. You will be responsible for overseeing Quality Assurance activities, managing robust quality systems, and fostering a culture of continuous improvement and collaboration across a highly matrixed organization. Key strategic responsibilities include:
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.
Championing a positive safety culture and promoting adherence to Safety, Health, and Environment (SHE) requirements aligned with corporate and local regulations.
Who You Are: You are a quality and compliance expert with a strong ability to lead cross-functional teams in a highly regulated, matrixed environment. Your expertise in stakeholder management and leadership has enabled you to deliver sustainable results while fostering a culture of collaboration and continuous improvement.
You possess a Bachelor’s degree in a scientific discipline (a graduate or higher-level degree strongly preferred).
You bring 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.
You have substantial expertise in Quality Assurance leadership, demonstrated by your successful oversight of critical quality systems, including deviation management, complaint handling, CAPA, and product release processes. You excel at embedding operational excellence in complex, large-scale manufacturing environments.
You have 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. Your expertise includes translating these regulations into lean, scalable operational strategies across the organization.
Beyond traditional pharmaceuticals, you bring deep knowledge and extensive experience with Advanced Therapy Medicinal Products (ATMP), specifically Cell Therapy manufacturing or Individualized Medicine, demonstrating your ability to navigate evolving regulatory landscapes and support groundbreaking therapies.
You are a strategic leader with a proven track record of influencing and collaborating across highly matrixed, global organizations. You have successfully aligned cross-functional teams from R&D, Quality, Manufacturing, Regulatory Affairs, and IT to drive shared goals and organizational success.
You possess exceptional communication skills with an executive presence to engage and guide senior leadership, the technical expertise to address inquiries from regulatory authorities, and the interpersonal skills to foster high-impact relationships across internal teams and external stakeholders.
You are a proactive and visible leader with a strong commitment to continuous improvement, operational readiness, safety culture, and business resilience. You inspire innovation, adaptability, and collaboration across teams while fostering a culture of agility and excellence.
Physical Requirements:
Work in office and laboratory environment
Lift up to 25 lbs may be required
Ability to sit, stand and move within work space for extended periods
May be required to sit at a computer terminal for extended periods
Ability to travel up to 30% to other sites as required
The expected salary range for this position based on the primary location of Oregon is $171,000 - $317,600. 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 in this link.
Relocation benefits are approved for this posting.
This is an on-site position; no remote options are offered at this time.
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