Associate Director: Sterility Assurance Lead
Location: BioMarin Shanbally Site (with global interaction across the BioMarin network)
Department: Quality
Reports To: Site Quality Lead
ROLE
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 individuals 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.
Position Overview
We are seeking a Sterility Assurance Lead to join our Quality organization at BioMarin Shanbally as we expand our manufacturing facility and commence commercial Drug Product (DP) manufacturing operations for global markets. This is a critical leadership role responsible for ensuring that all marketed and investigational drug products manufactured at our site meet the highest sterility and contamination control standards.
The successful candidate will act as a key influencer across the site and global operations, shaping contamination control strategies and driving compliance with regulatory expectations. This is an exciting opportunity for a proactive leader to define and implement sterility assurance programs, collaborate cross-functionally, and represent the site as a subject matter expert during audits and inspections.
Key Responsibilities
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Strategic Leadership: Own and continuously evolve the site’s Contamination Control Strategy, ensuring alignment with global standards and regulatory requirements.
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Regulatory Compliance & Influence: Implement regulatory expectations, maintain compliance with EU GMP Annex 1, 21 CFR, USP, EP, JP, and ICH guidelines, and stay current with emerging regulations and best practices.
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Training & Culture: Design and deliver robust training programs on aseptic processing, behaviors, and contamination control principles to embed a culture of sterility assurance across the site.
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Environmental Monitoring & Utilities: Establish and maintain environmental monitoring and clean utilities programs, ensuring proactive contamination control.
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Technical Expertise: Provide expert input on gowning, cleaning, sanitization strategies, microbiological method transfers, and contamination investigations.
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Investigations: Lead and guide the investigation of contamination-related deviations, non-conformances, and sterility failures. Perform root cause analysis, define corrective and preventive actions (CAPAs), and ensure timely closure of quality events. At the Shanbally site and within Global Operations.
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Data Analysis & Risk Mitigation: Review microbiological data trends, identify risks, and implement effective mitigation strategies.
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Global Collaboration: Partner with global Technology and Quality functions to ensure site alignment with industry best practices and BioMarin network standards.
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Continuous Improvement: Drive initiatives to enhance microbiological quality, operational efficiency, and inspection readiness.
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Facility Expansion Support: Lead microbiology aspects of facility expansions, including cleanroom qualification and sterilization systems.
Qualifications & Experience
Education:
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Bachelor’s degree in Microbiology, Biology, Pharmaceutical Sciences, or related discipline (Master’s or PhD preferred).
Experience:
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10–15+ years of progressive experience in microbiology within GMP-regulated pharmaceutical or biotechnology environments.
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Minimum 5 years in leadership roles, with proven ability to influence cross-functional teams and senior stakeholders.
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Significant hands-on experience supporting aseptic sterile fill-finish operations.
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Strong knowledge of EU GMP Annex 1 and global sterility assurance standards.
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Demonstrated success in leading contamination investigations and regulatory interactions.
Skills:
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Strategic thinker with strong problem-solving and decision-making abilities.
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Excellent communication and influencing skills across all organizational levels.
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Ability to interpret complex microbiological data and translate into actionable strategies.
Why Join Us?
This is a high-impact role at the heart of BioMarin’s mission to deliver life-changing therapies. You will have the opportunity to shape sterility assurance practices globally, lead critical initiatives, and work with a team committed to excellence and innovation.
