Manager, QA Validation

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.

QA Validation Manager

Hybrid (Min 3 days onsite)

Shanbally, Cork

Closing Date: 3rd July 2026

SUMMARY DESCRIPTION

BioMarin are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. The QA Validation team support validation activities across drug substance, drug product and secondary packaging operations.

Reporting to the Head of QA Validation, the QA Validation Manager will focus on leading the team that are responsible for oversight and support for all Validation / Qualification activities across the site, including, Qualification of new Equipment, Systems & Processes, maintenance of the validated state throughout the lifecycle and other related QA Validation responsibilities.  

RESPONSIBILITIES

• Lead the day-to-day activities of the QA Validation Manager to ensure consistent and compliant application of BioMarin Validation Policies, Practices & Procedures.
• Maintain oversight and support for all Validation / Qualification activities across the site, including, Qualification of new Equipment, Systems & Processes, maintenance of the validated state throughout the lifecycle.
• Responsible for talent management for the QAV Team including recruitment, performance management and continued professional development
• Provide technical leadership and training to QA Validation colleagues and contractors.
• Maintain the QAV department in an inspection-ready state. Interact directly with regulatory agency inspectors during audits.
• Active participation in the change control program for modifications to qualified systems
• Utilize risk assessment and problem-solving tools in approach to validation strategy, investigations, and continuous improvement initiatives.
• Provide guidance on compliance and regulations, and build competency within the team.
• Lead and / or represent quality / QAV in multi-departmental meetings & project teams.
• Develop effective working relationships with key stakeholders including Engineering, Manufacturing Sciences and Operations.
• Author or support the development of strategic validation documents including validation plans, validation master plans and global policy documents.
• Prepare, implement, and execute protocols and reports in accordance with relevant Standard Operating Procedures (SOP’s)
• Maintain current knowledge of industry standards and regulatory requirements validation techniques / approaches and systems utilized at BioMarin.
• Liaise with global support team to share learnings and implement improvements at a company wide scale.
• Other duties as assigned.

EDUCATION

• Bachelor of Sciences degree, or higher, in a technical discipline (engineering, chemical or biological sciences) is required

EXPERIENCE

• 8+ years’ experience in a cGMP regulated manufacturing environment, with demonstrated proficiency in Validation, Quality Assurance and GMP best practice.
• Demonstrated organizational and people management skills to co-ordinate a multi-discipline team & ensure high-performance throughout.
• Demonstrated stakeholder management skills to develop strong cross functional working relationships across all areas of the business.
• Strong communicator both verbally and in written format.
• Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
• Demonstrated ability to create and grow a continuous improvement culture.

CONTACTS

• This position will require interaction with multiple levels (from Technicians up through Sr. Management) in Quality Assurance, Quality Control, Manufacturing, Packaging Operations, Manufacturing Sciences, Engineering, Facilities, Regulatory Affairs and Human Resources.
• This position will also interact with BioMarin global groups across multiple disciplines for development and implementation of global QA Validation policies and procedures.

SUPERVISORY RESPONSIBILITY

• This position will have direct people management responsibilities for a team consisting of both FTE and temporary staff (8+ people) across multiple levels of experience. This position will look after all people management activities associated with this group.

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.