Pharma Technical Operations (PT) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply.  From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world.  We make our medicines at internal and external sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms.

This opportunity is located at Genentech’s Oceanside campus, a dedicated biologics drug substance manufacturing site specializing in commercial-scale production and rapid technology transfer. Utilizing dual stainless steel and state-of-the-art single-use manufacturing value streams, Oceanside plays a vital role in delivering life-saving therapies across Roche's commercial and clinical portfolio.

The Opportunity

As the Quality Site Head you are accountable for the design, qualification and ramp-up of the green field high volume facility’s operations, including strategic workforce planning, hiring the respective personnel, setting up the organization, all relevant processes and documentation (e.g. SOPs). You are responsible for ensuring timely ramp-up including the project management activities, IT systems and  definition of the processes in compliance with GMP/Quality requirements. You will identify timeline risks or bottlenecks for the project or future site operations and take appropriate actions. You will work closely with all the key areas to achieve ambitious goals in terms of on time, on cost and on scope delivery. 

You will work closely with the Site Head and other members of the Site Leadership team to shape excellence in operations and the strategy of the site. You are responsible for all Quality Operations affiliated with Quality Assurance and Quality Control business units for the Oceanside site and ensure that all processes and assets at the site are fully compliant with internal and external guidelines and regulations. You ensure effective use of resources and control of expenses to achieve maximum productivity; you develop and sustain robust scalable business processes and adjust and continuously improve them as needed. You are responsible for the achievement of complex and significant objectives through leadership and direction of significant multidimensional resources. You will build and maintain strong partnerships with the other departments on site within and beyond the Quality organisation to ensure site and department goals are achieved. You will also closely collaborate with other internal site Quality organisations and the global Quality organisation to support the network. 

Travel of up to 20% of the time is expected during the project phase.

Your responsibilities include the following:

• You will lead the Quality part of the User Team during the facility start-up project, prepare and transition into routine operations whilst building a high performing Quality team
• You will drive timely project execution through strategic thinking, technical and entrepreneurial understanding. 
• You will foster a strong mindset for safety, quality and compliance
• You will take purposeful and impactful decisions
• You will demonstrate disciplinary and professional leadership promotion and deployment of personnel including the assurance of adequate initial and ongoing training
• You will carry out employee appraisal reviews including performance assessment and salary responsibility
• You will define goals with employees and evaluate the achievement of goals. You will support the development of employees.

Who you are:

• You hold a Bachelor's degree in pharmaceutical, life sciences, physical sciences, or engineering with 15+ years of relevant bio/pharmaceutical experience in GMP regulated environments in Quality and preferably also manufacturing. 
• You possess significant professional experience in Quality Assurance/Control, including cross-functional team management and leadership.
• You have strong project management skills, ideally experience with ramping up new sites or operations.
• You have extensive professional experience with operations management in high-volume low cost device combination products or similar, and related documentation and processes knowledge.
• You have extensive knowledge of safety, quality systems and quality assurance concepts and systems, including the application of cGMPs.
• You have strong creative leadership skills, ability to build forward looking perspectives and remove barriers. Ability to inspire, adopt, coach and apply lean and agile ways of working. A consistent track record to perform against tight timelines in a highly complex and ambiguous environment. Expertise and experience in organizational change management and expertise in delivering a long-term vision is welcome.

Preferred:

• You have an advanced degree (Masters or PhD)
• You have international experience at multiple sites/locations

The expected salary range for this position based on the primary location for this position of California is $201,000 - $374,000. Actual pay will be determined based on experience, level, 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. 

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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