Quality Site Head, Oceanside
About The Position
The Quality Site Head is accountable for the design, qualification, and ramp-up of operations for a greenfield, high-volume biologics manufacturing facility at Genentech’s Oceanside campus. This includes strategic workforce planning, hiring, establishing the organization, and creating required processes and documentation such as SOPs. The role oversees project management, IT systems, and process definition to support timely ramp-up in compliance with GMP and Quality requirements, while identifying timeline risks and bottlenecks and taking appropriate action. Working closely with the Site Head and Site Leadership team, the Quality Site Head shapes site operational excellence and strategy. The position is responsible for Quality Operations across Quality Assurance and Quality Control at Oceanside, ensuring site processes and assets comply with internal and external guidelines and regulations. The role manages resources and expenses, develops and continually improves scalable business processes, leads significant multidimensional resources, and builds partnerships with site departments and internal and global Quality organizations. Travel of up to 20% is expected during the project phase.
Requirements
- Bachelor's degree in pharmaceutical sciences, life sciences, physical sciences, or engineering.
- 15+ years of relevant biopharmaceutical experience in GMP-regulated environments in Quality and preferably also manufacturing.
- Significant professional experience in Quality Assurance and/or Quality Control, including cross-functional team management and leadership.
- Strong project management skills; experience ramping up new sites or operations is ideal.
- Extensive professional experience in operations management for high-volume, low-cost device combination products or similar, including knowledge of related documentation and processes.
- Extensive knowledge of safety, quality systems, and quality assurance concepts and systems, including application of cGMPs.
- Creative leadership skills and the ability to build forward-looking perspectives and remove barriers.
- Ability to inspire, adopt, coach, and apply lean and agile ways of working.
- Track record of delivering against tight timelines in a highly complex and ambiguous environment.
Nice To Haves
- Advanced degree (Master's or PhD).
- International experience at multiple sites or locations.
- Expertise and experience in organizational change management and delivering a long-term vision.
Responsibilities
- Lead the Quality part of the User Team during the facility start-up project and prepare and transition the site into routine operations while building a high-performing Quality team.
- Drive timely project execution through strategic thinking and technical and entrepreneurial understanding.
- Foster a strong mindset for safety, quality, and compliance.
- Make purposeful and impactful decisions.
- Provide disciplinary and professional leadership, promote and deploy personnel, and ensure adequate initial and ongoing training.
- Conduct employee appraisal reviews, including performance assessment and salary responsibility.
- Define goals with employees, evaluate goal achievement, and support employee development.
- Oversee Quality Operations affiliated with the site's Quality Assurance and Quality Control business units.
- Ensure site processes and assets comply with internal and external guidelines and regulations.
- Manage resources and expenses to achieve productivity, and develop, sustain, adjust, and continuously improve robust scalable business processes.
- Identify project or future site-operation timeline risks and bottlenecks and take appropriate action.
- Build partnerships with site departments and collaborate with other internal site Quality organizations and the global Quality organization.
Benefits
- Discretionary annual bonus may be available based on individual and Company performance.
- Relocation benefits are approved for this posting.
- Position qualifies for benefits detailed in the linked benefits information.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
