Associate Director, QA CMO Oversight
Shanbally, Ringaskiddy, Cork (hybrid 2-3 days per week onsite)
Closing Date 9 Jan 2026
Overview
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. BioMarin’s Technical Operations group creates drugs for use in clinical trials and for scaling production of those drugs for the commercial market. The Associate Director, QA CMO Oversight is a key role within External Quality, Global External Operations and Global Supply Chain, providing risk-based quality oversight of Contract Manufacturing Organisations (CMOs) to ensure compliance with cGMP and regulatory requirements. The role serves as the Quality Single Point of Contact (SPOC) within Global External Operations, partnering with CMOs and internal stakeholders to maintain product quality, patient safety, and inspection readiness.
Responsibilities
Operational management: oversee daily quality operations of QA managers and qualified persons, ensuring timely and accurate quality requirements implementation and quality events resolution. Assess CMO health 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.
Compliance: ensure compliance with applicable GMP guidelines and regulations. Provide governance to ensure compliant batch certification/release for commercial products in line with EU directives and GMP Annexes.
Inspection readiness: ensure CMOs are inspection‑ready and participate in GxP audits and regulatory inspections.
KPI monitoring: monitor and analyse quality key performance indicators (KPIs), trends, and CAPAs to ensure operational efficiency and effectiveness.
Collaboration: collaborate with cross‑functional teams to align on GMP requirements and quality standards, develop and deliver GMP training programs, and maintain documentation and records.
Global initiatives: support harmonisation efforts related to quality and compliance, leverage global quality tools and systems, and drive change management through communication.
Budget management: develop and manage the regional quality budget, ensuring cost‑effective operations while maintaining high quality levels.
Stakeholder collaboration: collaborate with internal and external stakeholders to drive quality across the BioMarin supply chain.
Process improvement: identify and implement quality process improvements to enhance operational efficiency.
Leadership of change initiatives: support and drive change management requirements, develop the vision for the organisation and empower team members.
Travel: approximately 20%.
Scope
This role supports the efficient oversight and disposition of lifesaving therapies in compliance with applicable regulations. Decisions made in this role mitigate risks for the business while ensuring timely delivery to patients.
Attributes
Firm 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.
High level of accountability and ability to be a change agent in a regulated industry.
Flexibility to deal with changing priorities.
Strong interpersonal, communication, and influencing skills.
Proactive and energetic outlook.
Collaboration with team members, peers, and senior management.
Ability to work independently and manage time effectively.
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 experience in pharmaceutical quality assurance, 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, able to work in a fast‑paced environment.
Strategic mindset with 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.
Proficiency in QMS tools and systems, 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
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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