Associate Director, QA CMO Oversight

Location: Cork, Ireland Category: Quality

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.

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 – and 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. 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.

Associate Director, QA CMO Oversight

Shanbally, Ringaskiddy, Cork

(hybrid 2-3 days per week onsite)

Closing Date 9 Jan 2026

The Associate Director, QA CMO Oversight is a key role as part of External Quality, Global External Operations (GEO) and Global Supply Chain (GSC) organizations. The position will provide risk-based quality oversight of Contract Manufacturing Organisations (CMOs) to ensure compliance with cGMP and regulatory requirements, and will act as the Quality Single Point of Contact (SPOC) within Global External Operations (GEO), partnering with CMOs and internal stakeholders to maintain product quality, patient safety, and inspection readiness.

This strategic role involves leading 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 designated person should have strong leadership skills, a deep understanding of Good Manufacturing Practices, and the ability to drive continuous improvement initiatives.

The role will partner with, and influence with Quality Units, Global External Operations, Technical Development Services, Regulatory Affairs, Supply Chain and Finance to uphold the highest standards of GMP practices. This role ensures that all BioMarin products are manufactured and released/dispositioned in accordance with applicable regulations. This role builds strong Quality to Quality relationships with CMO sites, to ensure effective communications supporting quality oversight.

This position requires a broad range of knowledge and experience with biologic processes applicable to drug development, drug substance, drug product, finished packed product, analytical testing methods, and understanding of the international regulatory landscape.

Accountabilities include stage gate recommendations / decisions for quality, management of Quality Technical Agreements with external parties, applying disposition recommendations for deviations / OOSs, quality approval of changes, deviations, risk assessments.

Responsibilities

Operational Management: Ensure overseeing daily quality operations of the QA Managers and Qualified Person(s), ensuring timely and accurate quality requirements implementation and quality events resolution. Assess CMO health and escalate risks - 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.
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 Annexes 16.
Ensure CMOs are inspection-ready; participate, where required in GxP audits and regulatory inspections.
Monitor and report and analyse quality key performance indicators (KPIs) metrics, trends, and CAPAs (Corrective and Preventive Actions) to ensure operational efficiency and effectiveness.
Collaborate with cross-functional teams to ensure alignment on GMP requirements and quality standards.
Ensure development and delivery of GMP training programs for internal teams and external partners.
Ensure maintenance of documentation and records to support GMP compliance and regulatory commitments.
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.
Compliance: Ensure compliance with all relevant regulations, including GMP, health and safety standards, and BioMarin policies
Process Improvement: Identify and implement quality process improvements to enhance operational efficiency and to support the internal stakeholders' initiatives.
Stakeholder Collaboration: Collaborate with internal and external stakeholders to drive quality across the BioMarin supply chain.
Technology Utilization: Leverage global quality tools and systems to streamline operations and compliance.
Change Leadership: As a member of the External Quality Operations Leadership team support and drive the change management requirements through communication internally and externally, developing the vision for the organization and empowering the team members to make effective decisions.

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 of critical nature in mitigating risks for the business while ensuring BioMarin’s commercial and clinical products are delivered to patients in a timely and compliant manner. The candidate should demonstrate the following attributes:

A 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 both internally and externally
Possess a high level of accountability and demonstrate an 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 working with all levels and within an environment of constant change
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 experience in pharmaceutical quality assurance, including CMO oversight, with at least 3 years 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 effectively work autonomously and independently
Understanding of Quality Tools: e.g., Veeva QMS, SAP, or like 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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