Associate Director, QA CMO Oversight
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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 to understand the underlying causes of genetic conditions and create transformative medicines using a variety of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – to create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well‑understood biology and provide an opportunity to be first‑to‑market or offer a substantial benefit over existing therapeutic options.
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. 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 coordinate the worldwide movement of our drugs to patients.
Location & Schedule
Shanbally, Ringaskiddy, Cork. Hybrid 2‑3 days per week onsite.
Closing Date
9 Jan 2026
Position Overview
The Associate Director, QA CMO Oversight is a key role within the External Quality, Global External Operations (GEO) and Global Supply Chain (GSC) organizations. The position provides risk‑based quality oversight of Contract Manufacturing Organisations (CMOs) to ensure compliance with cGMP and regulatory requirements, and acts as the Quality Single Point of Contact (SPOC) within GEO, partnering with CMOs and internal stakeholders to maintain product quality, patient safety and inspection readiness.
This strategic role leads a team of Quality Managers and Qualified Person(s) to ensure efficient and effective quality oversight of externally manufactured drug substance, drug product and packaging CMOs, and subsequent release/disposition. The role requires strong leadership skills, deep understanding of Good Manufacturing Practices and the ability to drive continuous improvement initiatives.
Responsibilities
Operational Management: Ensure overseeing daily quality operations of QA Managers and Qualified Person(s), implementing quality requirements and resolving quality events. Assess CMO health, elevate risks and drive remediation plans.
Team Leadership: Lead, mentor and develop a team of Quality Managers and Qualified Persons, fostering a culture of excellence and continuous improvement.
Regulatory Compliance: Ensure compliance with applicable GMP Guidelines and Regulations. Provide leadership, coaching and governance to ensure compliant batch certification/release for commercial products in line with EU Directives 2001/83/EC and EU GMP Annex 16.
Inspection Readiness: Ensure CMOs are inspection‑ready; participate, where required, in GxP audits and regulatory inspections.
Performance Monitoring: Monitor, report and analyse quality KPIs, trends and CAPAs to ensure operational efficiency and effectiveness.
Cross‑Functional Collaboration: Collaborate with cross‑functional teams to ensure alignment on GMP requirements and quality standards.
Training: Ensure development and delivery of GMP training programs for internal teams and external partners.
Documentation: Ensure maintenance of documentation and records to support GMP compliance and regulatory commitments.
Global Initiatives: Support global initiatives and harmonization efforts related to quality and compliance.
Budget Management: Develop and manage the regional quality budget, ensuring cost‑effective operations while maintaining high quality levels.
Change Leadership: Support and drive the change management requirements through communication internally and externally, developing a vision for the organization and empowering the team.
Scope
This role is responsible for supporting the efficient oversight and disposition of lifesaving therapies in compliance with applicable regulations. Decisions made in this role are critical in mitigating risks for the business while ensuring BioMarin’s commercial and clinical products are delivered to patients in a timely and compliant manner.
Candidate Attributes
Strong commitment to BioMarin’s cultural beliefs and values.
Consistent track record of exceeding objectives within area of influence.
Ability to achieve results through others without direct reporting lines.
Strong problem‑solving skills with a global focus both internally and externally.
High level of accountability and ability to be a change agent in a highly regulated industry.
Flexibility and ability to deal with changing priorities without losing sight of the overall business.
Strong interpersonal, communication and influencing skills.
Proactive and energetic outlook with an unwillingness to accept the status quo.
Interaction and collaboration with team members, peers and senior management.
Ability to work independently with strong time‑management skills.
Travel – Approximately 20 %.
Education
Bachelor’s or advanced degree in Pharmacy, Chemistry, Biochemistry, Microbiology or related scientific discipline. Eligible EU Qualified Person (QP) or fully credentialed QP strongly preferred.
Experience
8+ years of pharmaceutical quality assurance experience, including CMO oversight, with at least 3 years of people‑management experience.
In‑depth knowledge of GMP Guidelines and Regulations.
Detail‑oriented, analytical thinker, problem‑solver and able to work in a fast‑paced environment.
Strategic mindset with hands‑on operational execution.
Strong leadership and team‑management skills, excellent communication and interpersonal skills.
Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk.
Proficiency in QMS tools and systems, and a solid understanding of external quality oversight principles.
Ability to work autonomously and independently.
Understanding of Quality Tools: e.g. Veeva QMS, SAP or similar technologies.
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.
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