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Associate Director, Sterility Assurance Lead
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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…
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Sisk —Cork, County Cork
NEBOSH Diploma or equivalent qualification in occupational health and safety. Postgraduate qualification in health and safety, risk management or related…

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Associate Director, Sterility Assurance Lead

BioMarin -
Cork, County Cork

Apply Now

Job details

Full-time

Qualifications

Biology
Doctoral degree
Master's degree
Bachelor's degree
Cleaning
Leadership
Communication skills

Full job 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.

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.

Associate Director: Sterility Assurance Lead

Location: BioMarin Shanbally Site (with global interaction across the BioMarin network)

Reports To: Site Quality Lead

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

Strategic Leadership: Own and continuously evolve the site’s Contamination Control Strategy, ensuring alignment with global standards and regulatory requirements.
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.
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.
Environmental Monitoring & Utilities: Establish and maintain environmental monitoring and clean utilities programs, ensuring proactive contamination control.
Technical Expertise: Provide expert input on gowning, cleaning, sanitization strategies, microbiological method transfers, and contamination investigations.
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.
Data Analysis & Risk Mitigation: Review microbiological data trends, identify risks, and implement effective mitigation strategies.
Global Collaboration: Partner with global Technology and Quality functions to ensure site alignment with industry best practices and BioMarin network standards.
Continuous Improvement: Drive initiatives to enhance microbiological quality, operational efficiency, and inspection readiness.
Facility Expansion Support: Lead microbiology aspects of facility expansions, including cleanroom qualification and sterilization systems.

Qualifications & Experience

Education:

Bachelor’s degree in Microbiology, Biology, Pharmaceutical Sciences, or related discipline (Master’s or PhD preferred).

Experience:

10–15+ years of progressive experience in microbiology within GMP-regulated pharmaceutical or biotechnology environments.
Minimum 5 years in leadership roles, with proven ability to influence cross-functional teams and senior stakeholders.
Significant hands-on experience supporting aseptic sterile fill-finish operations.
Strong knowledge of EU GMP Annex 1 and global sterility assurance standards.
Demonstrated success in leading contamination investigations and regulatory interactions.

Skills:

Strategic thinker with strong problem-solving and decision-making abilities.
Excellent communication and influencing skills across all organizational levels.
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.

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.

Apply Now

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