Senior Manager, External QA Validation

The Manager/Sr. Manager, External QA Validation (Technical Quality) serves as a Quality technical lead for process validation and technology transfer activities across BioMarin’s external manufacturing network, providing strategic Quality oversight of process validation, cleaning validation, equipment/facility qualification, and other validation activities supporting products manufactured at Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs).

This role is accountable for establishing and maintaining Quality expectations for validation and technology transfer, providing risk-based oversight throughout the transfer and validation lifecycle, and ensuring that external manufacturing processes and associated control strategies are appropriately qualified, validated, and maintained in accordance with BioMarin standards and global regulatory expectations.

The role partners closely with BioMarin’s Technical Development and Services (TDS), Global External Operations (GEO), External Quality Operations, Product Quality Leaders (PQL), and external partners to support successful technology transfers, validation readiness, commercial manufacturing and continuous improvements across the external network.

BS in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related technical discipline with at least 8–10+ years of relevant experience.

Significant experience in cGMP-regulated biopharmaceutical environments, with direct experience in Quality Assurance, validation, manufacturing sciences, technical operations, or related functions.

Demonstrated experience with process validation and validation lifecycle management, including process performance qualification.

Demonstrated experience supporting technology transfer and manufacturing scale-up in a regulated environment.

Strong understanding of global regulatory requirements and industry expectations applicable to validation and technology transfer, including relevant FDA, EMA, ICH, and EU GMP requirements.

Experience with external manufacturing/testing networks (CMOs/CDMOs/CTOs) strongly preferred.

Strong technical judgement, problem-solving, communication, and stakeholder-management capabilities.

Demonstrated ability to lead cross-functional teams and influence technical decisions without direct authority.

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.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training. Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

The salary range for this position is: $121,600 to $167,200. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.