Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

About Technical Operations

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.

• Lead the global external quality function responsible for oversight of CMOs, CDMOs, contract testing laboratories, packagers, and other critical suppliers. 
• Establish and maintain a risk-based external quality oversight model across commercial and clinical products. 
• Ensure compliance of external manufacturing operations with applicable global GMP,  ICH, and regional regulatory requirements. 
• Provide quality oversight for small molecules, biologics/large molecules, APIs, drug substance, and finished products throughout the product lifecycle. 
• Oversee key external quality systems, including deviations, investigations, CAPA, change control, OOS/OOT, data integrity, validation, documentation, and training. 
• Ensure robust supplier qualification, onboarding, performance monitoring, and periodic review of external partners. 
• Lead quality input and decision-making for technology transfers, product launches, lifecycle changes, site changes, and new supplier introductions. 
• Ensure effective quality governance through quality agreements, escalation processes, performance metrics, and business review mechanisms. 
• Lead inspection readiness and support regulatory inspections, audits, and remediation activities involving external sites. 
• Escalate significant quality or compliance risks to senior leadership with clear risk assessments and recommended actions. 
• Partner with internal stakeholders to support product disposition, supply continuity, issue resolution, and market action management, as needed. 
• Build and lead a high-performing global external quality team and foster a proactive, risk-based quality culture. 

• Accountable for Quality and Compliance decisions across for CMO’s, CDMO’s, CTO’s, including product disposition decisions as per cGMP’s. 
• Sets Quality and Compliance goals and objectives; establishes metrics to continuously monitor site Quality performance; ensures goals and objectives are effectively met. 
• Lead the External Quality Site Quality Review Team (SQRT) processes to ensure external Manufacturers 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 (Corrective and Preventive Actions) and HA (Health Authorities) 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 where applicable (e.g., FDA (Food and Drug Administration), EMA (European Medicine Agency) HPRA (Health Products Regulatory Authority), PMDA (Pharmaceuticals and Medical Devices Agency), etc.), ensuring external sites 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 GEO.
• Partner and align with Quality Site Heads to drive Global Quality Strategic initiatives in alignment with TOPS (Technical Operations) strategic objectives.
• Interface with Senior Management to set policy on product quality and assure adherence to company and governmental standards.

• 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 Global External Operations, Supply Chain Distribution, Global Quality Functions, Regulatory, Tech. Dev. Clinical Operations, MSAT (Manufacturing Science and Technology) and Finance to achieve business goals.
• Has excellent negotiating skills and enterprise mindset to achieve win-win outcomes in demanding 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 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.

Education

• 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 cGMP’s (Current Good Manufacturing Practices), 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.  

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. 

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.