Quality Site Head, Oceanside

Genentech • Oceanside, CA

6d • Onsite

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. This includes workforce planning and hiring, establishing the organization, developing processes and documentation such as SOPs, and ensuring project activities, IT systems, and processes are implemented on time and in compliance with GMP and Quality requirements. The role identifies project and operational timeline risks and bottlenecks, takes appropriate action, and works with key stakeholders to deliver on time, on cost, and on scope.

The position leads Quality Operations across the site’s Quality Assurance and Quality Control business units, ensuring processes and assets comply with internal and external guidelines and regulations. The Quality Site Head manages resources and expenses, develops and continuously improves scalable business processes, and leads significant multidimensional resources toward complex objectives. The role partners with the Site Head, the Site Leadership team, other site departments, internal site Quality organizations, and global Quality to support site goals and the broader network.

During the project phase, travel of up to 20% is expected. The Quality Site Head leads the Quality User Team during facility start-up and transitions the site into routine operations while building a high-performing Quality team. Responsibilities also include personnel leadership, training, performance and salary responsibilities, goal setting, and employee development.

Requirements

• Bachelor’s degree in pharmaceutical, life sciences, physical sciences, or engineering.
• 15+ years of relevant bio/pharmaceutical 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 in operations management for 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, the ability to build forward-looking perspectives, and the ability to remove barriers.
• Ability to inspire, adopt, coach, and apply lean and agile ways of working.
• Consistent track record of performing against tight timelines in a highly complex and ambiguous environment.

Nice To Haves

• Experience ramping up new sites or operations.
• Expertise in organizational change management and delivering a long-term vision.
• Advanced degree (Master’s or PhD).
• International experience at multiple sites or locations.

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.
• Lead and direct significant multidimensional resources toward complex and significant objectives.
• Plan the workforce, hire personnel, establish the organization, and set up processes and documentation, including SOPs.
• Ensure timely facility ramp-up, including project management activities, IT systems, and processes compliant with GMP and Quality requirements.
• Identify project or future-site operational timeline risks and bottlenecks and take appropriate action.
• Ensure Quality Operations across the site’s Quality Assurance and Quality Control business units and compliance of site processes and assets with internal and external guidelines and regulations.
• Use resources effectively and control expenses to achieve productivity; develop, sustain, and continuously improve robust, scalable business processes.
• Build and maintain partnerships with other site departments, internal site Quality organizations, and the global Quality organization.
• 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.

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 company benefits; details are provided through a link in the posting.

What This Job Offers

• Job Type: Full-time
• Career Level: Director