External QA Validation Lead – Tech Transfer & GMP

BioMarin Pharmaceutical Inc.; Novato (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

BioMarin Pharmaceutical Inc. in Novato, CA, seeks a Manager/Sr. Manager, External QA Validation (Technical Quality) to lead quality oversight for process validation and technology transfer across BioMarin’s external manufacturing network.

You will ensure validated, compliant transfers and maintain alignment with global regulatory expectations. This role requires 8–10+ years in a cGMP biopharmaceutical environment, strong QA leadership, and cross-functional collaboration with CMOs/CDMOs.

Qualifications

• BS in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related technical discipline with 8–10+ years of relevant experience.
• Strong understanding of global regulatory requirements and industry expectations applicable to validation and technology transfer, including FDA, EMA, ICH, and EU GMP requirements.

Responsibilities

• Serve as the External Quality technical SME for validation and technology transfer across BioMarin’s external manufacturing network.
• Act as the Quality lead for technology transfers of manufacturing processes to CMOs/CDMOs, establishing effective Quality partnerships and supporting planned, predictable, and compliant transfer execution.
• Define and maintain Quality validation expectations and standards for externally manufactured products in alignment with BioMarin Global Policies, procedures, industry standards, and regulatory requirements.
• Provide Quality oversight of validation lifecycle activities, including process validation/PPQ, cleaning validation, equipment and facility qualification, and other GMP validation activities.
• Review and approve validation strategies, Validation Master Plans, protocols, reports, risk assessments, and other GMP documentation with the role’s accountability.
• Assess validation and technology transfer risks, identify gaps, recommend appropriate mitigation strategies, and elevate significant risks to Technology Transfer Lead and Quality leadership.
• Provide Quality oversight of technology transfer readiness, including assessment of CMO/CDMO capabilities, validation approaches, manufacturing controls, and GMP readiness prior to execution.
• Partner with Technical Development and Services and Global Quality representatives to ensure appropriate development and implementation of process parameters, in-process controls, specifications, and controls strategies, while maintaining clear functional accountabilities.
• Represent External QA Validation on cross-functional governance and technical forums supporting technology transfer, validation, and external manufacturing.
• Maintain current knowledge of evolving industry standards, regulatory requirements, and validation approaches applicable to biologics and pharmaceutical manufacturing.
• Influence technical and Quality decisions across internal and external organizations without direct authority, building strong partnerships with CMOs/CDMOs and internal stakeholders.
• Other duties as assigned.
• Periodic travel is required.

Skills

Technical judgement

Problem-solving

Communication

Stakeholder management

Education

BS in Engineering or related technical discipline

Job description

BioMarin Pharmaceutical Inc. in Novato, CA, seeks a Manager/Sr. Manager, External QA Validation (Technical Quality) to lead quality oversight for process validation and technology transfer across BioMarin’s external manufacturing network.

You will ensure validated, compliant transfers and maintain alignment with global regulatory expectations. This role requires 8–10+ years in a cGMP biopharmaceutical environment, strong QA leadership, and cross-functional collaboration with CMOs/CDMOs.