Quality Site Head, Novato Operations, Technical Operations

Role: Executive Director: Site Quality Head, Novato

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients' lives.

Job Summary

The Executive Director, Quality Site Head is a highly motivated technically knowledgeable leader with proven abilities to lead the Quality Organization to ensure the site reliably comply with current Good Manufacturing Practices (cGMP's), has harmonized quality systems, quality assurance, quality control and compliance processes across the Novato, CA Site. The Novato Site manufactures commercial and clinical products using different platforms including Biologics, Gene Therapies, and E coli production for manufacture (VV, DS, DP, etc.).

The Quality Site Head reports to the SVP, Chief Quality Officer, and is responsible for the Quality Unit, Quality Control, Quality Assurance, Quality Compliance and Site Quality System. This position will sit on the Global Quality Leadership Team and Novato Site Leadership Team.

The incumbent will hire, train, develop and retain a highly skilled workforce; drive operational excellence to improve Quality and productivity; effectively implement new quality technologies, and create an environment where our people will be engaged, grow, and thrive.

The SQH coordinates at local level the implementation, follow up and completeness of all related Quality programs, documentation and Quality reporting while ensuring that the proper quality organization is in place.

This position required a broad range of knowledge and experience with biologic processes, drug development, analytical testing methods, lot disposition decisions, tech transfers, and understanding of the international regulatory landscape.

This leader will develop a high performing team and provides leadership and guidance to the organization. By providing strategic direction, setting clear expectations, goals and metrics, the leader is accountable for all activities related to commercial production generated at Novato. These products and late-stage projects span. The leader would champion continuous improvement to reduce variability in commercial production and to maintain high quality product.

SCOPE

People Leader, responsible for the Novato Quality Organization (Quality Unit); Quality Control, Quality Assurance, Quality Compliance and Site Quality System, with a team of nearly 200 employees.

Job Responsibilities:

• Leads Quality and Compliance across Novato site, driving adherence to applicable cGMP regulations and company policies and procedures
• Accountable for Quality and Compliance decisions across the Novato site, including product disposition decisions as per cGMP's.
• Sets Quality and Compliance goals and objectives for Novato sites; establishes metrics to continuously monitor site Quality performance; ensures goals and objectives are effectively met.
• Lead the Site Quality Review Team (SQRT) process to ensure site regulatory compliance and to identify opportunities for continuous improvement of products, processes, and the quality system itself.
• Provide technical direction and leadership to direct the quality review of product documentation, including deviations, investigations CAPAs and HA observations and represents Quality in site governance meetings
• Shape and influence Quality perspective and actions based on regulatory inspections and third-party audits.
• Oversees compliance audits and regulatory inspections by health authorities (e.g., FDA, EMEA, PMDA, etc.), ensures internal Novato site inspection readiness
• Provide expert interpretation and application of regulatory guidelines to ensure manufacturing operations, facilities, and documentation adhere to regulatory requirements, company procedures, and are consistent with industry standards.
• Sponsors Quality and Compliance harmonization, integration, and continuous improvement initiatives across the site.
• Partner and align with Quality Site Heads to drive Global Quality Strategic initiatives in alignment with TOPS strategic objectives.
• Interface with Senior Management to set policy on product quality and assure adherence to company and governmental standards.

Leadership Responsibilities:

Embodies a compliance, quality and continuous improvement mindset.

Executing for Results: Maintains high standards of performance consistently collaborates with all stakeholders and follows through on commitments. Takes the long view, and when faced with challenging obstacles, exemplifies always doing what is in the best interest of patients.

Conveys a sense of urgency and drives issues to closure. Makes timely decisions when a quick response is required and ensures evaluation of several options when needed.

Work closely & collaboratively with Site Operations, Global Quality Functions, Regulatory, Tech. Dev. Clinical Operations, MSAT and Finance to achieve business goals.

Has excellent negotiating skills and enterprise mindset to achieve win-win outcomes in difficult situations (not related to quality decision).

Build, develop and lead an engaged workforce and drive a high-performance culture that is innovative, agile, open to change, and constantly learning in a high growth and evolving industry

Manage the selection, hiring and training of personnel on company and department policies, systems, and processes.

Leads Novato Quality AOP, Forecast and Long-Range financial budgeting process and ensures adherence to budget

Sponsor project teams and champion the effective deployment of new technologies, and systems to improve quality, optimize productivity, reduce cycle times, and deliver pipeline.

Leads Novato Quality AOP, Forecast and Long-Range financial budgeting process and ensures adherence to budget

EDUCATION

BS/MS/B.Sc./M.Sc./PhD in the life sciences or engineering.

EXPERIENCE

• At least 15+ years of relevant leadership experience in Quality including Site Quality leadership and at least 10+ years supervising, managing, and directing teams
• Demonstrated knowledge of cGMPs, Global Health Authority regulations and guidelines, Quality Systems, and technical expertise in Drug Substance/Drug Product/Finished Goods manufacturing processes and Combination Products.
• Strong commercial bio/pharma manufacturing experience, and excellent people leadership expertise. Experience in Biologics or Cell/Gene Therapy manufacturing is required, Cell/Gene Therapy experience preferred
• Exposure across multiple Quality and Technical Operations functions. Experience leading Quality in multi-product manufacturing plants, with strong knowledge and experience with Health Authority inspections and interactions
• Excellent interpersonal and collaboration skills communicates well orally and in writing.
• Demonstrated ability in implementing processes to deliver results
• Financial management experience, awareness, and strong acumen.

CONTACTS

This position will interact with all other departments throughout the organization. This position will partner and influence with Quality, Regulatory Affairs, Compliance, Process Sciences, Finance, MSATS, and other departments as required. This position requires constant contact with Senior Management across the organization.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.