Quality Site Head, Oceanside
About The Position
The Quality Site Head is accountable for designing, qualifying, and ramping up operations at a greenfield, high-volume biologics manufacturing facility at Genentech’s Oceanside campus. Responsibilities include strategic workforce planning and hiring, establishing the organization and its processes and documentation, and ensuring timely ramp-up through project management, IT systems, and processes that comply with GMP and Quality requirements. The role identifies project and future operational risks or bottlenecks and takes appropriate action, working across key areas to achieve on-time, on-cost, and on-scope delivery. Working with the Site Head and Site Leadership team, the Quality Site Head helps shape operational excellence and site strategy. The role is responsible for Quality Operations across the site’s Quality Assurance and Quality Control business units, ensuring processes and assets comply with internal and external requirements. It also involves effective resource and expense management, establishing and continuously improving scalable business processes, and leading significant multidimensional resources toward complex objectives. The role builds partnerships with site departments and collaborates with internal site and global Quality organizations to support the network. The role leads the Quality portion of the facility start-up User Team and prepares and transitions the site into routine operations while building a high-performing Quality team. 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/Control, including cross-functional team management and leadership.
- Strong project management skills.
- Extensive professional experience with operations management in high-volume, low-cost device combination products or similar, and knowledge of related documentation and processes.
- Extensive knowledge of safety, quality systems, and quality assurance concepts and systems, including application of cGMPs.
- Strong 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.
- Consistent track record of performing against tight timelines in highly complex and ambiguous environments.
- Travel up to 20% during the project phase.
Nice To Haves
- Advanced degree (Master’s or PhD).
- International experience at multiple sites or locations.
- Experience ramping up new sites or operations.
- Expertise 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.
- Design, qualify, and ramp up the greenfield facility’s operations, including workforce planning, hiring, organization setup, and creation of processes and documentation such as SOPs.
- Manage project activities, IT systems, and process definition to ensure timely ramp-up in compliance with GMP and Quality requirements.
- Identify project timeline risks and bottlenecks for the project or future site operations and take appropriate action.
- Lead Quality Operations across the Oceanside site’s Quality Assurance and Quality Control business units and ensure site processes and assets comply with internal and external guidelines and regulations.
- Manage resources and expenses to achieve productivity, and develop, sustain, and continuously improve robust, scalable business processes.
- Build partnerships with site departments and collaborate with internal site Quality organizations and the global Quality organization.
- Work with the Site Head and Site Leadership team to shape operational excellence and site strategy.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Relocation benefits are approved for this posting.
- The position qualifies for benefits detailed in the referenced benefits link.
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What This Job Offers
Job Type
Full-time
Career Level
Director
