Senior Manager, QA Systems and Compliance at BioMarin… · Ireland

Description

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

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.

Senior Manager, QA Systems and Compliance

Shanbally, Ringaskiddy, Cork

Closing Date: 5 June 2026

Essential Job Functions:

• Act as Business Process Owner/Manager for assigned Quality Systems, demonstrating extensive leadership in system oversight and strategic direction.
• Assess GMP and regulatory compliance risks and develop effective risk mitigation strategies in collaboration with accountable stakeholders.
• Champion and actively contribute to the wider Quality Systems & Compliance team, leveraging deep expertise to deliver guidance and mentorship to colleagues, elevating overall team performance.
• Support site audit and inspection activities, including preparation, participation, and follow-up actions.
• Direct or oversee activities related to the Site Quality Management Review process, ensuring thorough and insightful evaluation of quality performance.
• Collaborate with cross-functional leadership teams to identify, design, and implement transformative system improvements that meet evolving regulatory requirements and strategic business objectives.
• Analyse system performance using metrics, KPIs, and trending to drive data-based decision making.
• Provide expert troubleshooting support and respond to business and compliance queries.
• Benchmark industry best practices and identify opportunities to enhance system robustness and efficiency.
• Liaise with global Quality colleagues to share learnings, ensure alignment, and support consistency across the network.

People Leadership & Development

• Develop, coach, and mentor Quality Specialists, supporting both technical capability and professional growth.
• Lead a team of specialists, associates, and contingent workers within the Quality Systems & Compliance function (current or future), including responsibilities for:
  • Talent acquisition and effective onboarding
  • Performance management and talent development
  • Comprehensive resource planning and budget oversight
  • Inspection preparedness and compliance strategy
  • Foster a strong quality culture, accountability, and continuous improvement mindset.
  • Perform other duties consistent with the role as assigned.

Education:

• Bachelor’s degree in Pharmaceutical Sciences, Process Engineering or related discipline.

Experience:

• 15–20+ years’ experience within GMP-regulated pharmaceutical or biotechnology environments
• 3-5 years in leadership roles, with experience in people management and a proven ability to influence cross-functional teams and stakeholders.
• Significant hands-on experience supporting regulatory inspections.
• Knowledge of EU GDP Guidelines and regional regulatory requirements.
• Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk

Key Requirements:

• Strong working knowledge of GMP and Quality Systems in a regulated environment
• Proven ability to lead, coach, and develop technical professionals
• Experience managing or improving quality systems and processes
• Strong stakeholder engagement and communication skills
• Ability to operate effectively in a matrix and global environment

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.