Senior Quality Assurance Manager/Quality Assurance Director

Join Genentech's Pharma Technical - Hillsboro Innovative Therapies (HIT) team in Hillsboro, Oregon, where we are pioneering cell and gene therapy platforms. In this pivotal role, you will aid in the start-up and operation of a manufacturing facility designed to handle high-throughput patient treatment modalities. You will be responsible for ensuring quality oversight for clinical GMP manufacturing and batch release. Additionally, you will contribute to the technology transfer projects by establishing processes that enable successful HIT GMP manufacturing and clinical supply to patients.

The Opportunity:

As a Senior Quality Assurance Manager / Quality Assurance Director, you will be responsible for overseeing and managing quality assurance activities to ensure compliance and successful execution of clinical and commercial manufacturing within the HIT team. Additionally, you will:

• Collaborate closely with Genentech Quality Product Leaders, Development groups, and various HIT functional teams to maintain quality operations

• Plan and oversee quality oversight for clinical manufacturing activities, ensuring timely investigations, CAPAs, and batch releases

• Develop and foster cross-functional relationships to sustain compliance and enable on-time product delivery

• Serve as an escalation point for resolving manufacturing issues and discrepancies, including CAPAs and quality deviations

• Foster a speak-up culture of learning and safety through discussions and coaching, guiding teams on practical yet compliant solutions

• Manage Quality aspects of operational start-up activities, including technology transfer projects, ensuring compliance with cGMPs, SOPs, and batch records

• Maintain significant on-floor presence to address issues, identify improvement opportunities, and drive resolutions

• Lead and coach Quality Assurance Specialists, overseeing their professional development and performance evaluations

Who You Are:

Note: This position may be hired at the Senior Manager or Director level, depending on the candidate's qualifications.

Senior Quality Assurance Manager

• Bachelor's degree in life sciences, physical sciences, engineering, or a related discipline

• Minimum of 8 years of relevant experience in the bio/pharmaceutical industry, including at least 3 years in a leadership role

• Proven knowledge and application of safety practices, business/quality systems, and quality assurance concepts, including current Good Manufacturing Practices (cGMPs)

• Demonstrated ability to independently resolve complex problems using functional expertise, as evidenced by specific examples of problem-solving in previous roles

• Documented experience in leading and inspiring teams through coaching, mentoring, and accountability, demonstrated through leadership success stories and performance metrics

• Preferred experience with Advanced Therapy Medicinal Products (ATMPs), such as individualized therapies (autologous, allogeneic), supported by specific project involvement

The expected salary range for the Senior Quality Assurance Manager position based in Oregon is $122,500 (min) - $175,000 (mid) - $227,500 (max). 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.

Benefits

Relocation benefits are approved for this posting.

This is an on-site role, no remote or hybrid options are available.

Quality Assurance Director

• Bachelor's degree in life sciences, physical sciences, engineering, or a related discipline

• Minimum of 12 years of relevant experience in the bio/pharmaceutical industry, including at least 5 years in a leadership role

• Extensive knowledge of safety practices, business/quality systems, and quality assurance concepts, with demonstrated ability to interpret and apply cGMPs in a phase-appropriate manner, evidenced by successful project executions

• Proven expertise in resolving complex problems and initiating continuous improvement initiatives, evidenced by specific examples and outcomes

• Demonstrated ability to influence peers and senior leadership to align on practical implementation strategies for GMP production, as evidenced by successful alignment and implementation outcomes

• Preferred experience with Advanced Therapy Medicinal Products (ATMPs), such as individualized therapies (autologous, allogeneic), supported by specific project involvement

The expected salary range for Quality Assurance Director position based in Oregon is $141,960 (min) - $202,800 (mid) - $263,640 (max). 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.

Benefits

Relocation benefits are approved for this posting.

This is an on-site role, no remote or hybrid options are available.

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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.