External QA Validation Lead, Tech Transfer

biomarin; Novato (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

BioMarin in Novato, CA is seeking a Manager/Sr. Manager, External QA Validation to lead quality oversight of process validation and technology transfer across BioMarin’s external manufacturing network.

You will partner with TDS, GEO, and PQL teams to ensure validated, compliant manufacturing and transfer readiness, while maintaining regulatory alignment with FDA/EMA expectations. Travel may be required.

Qualifications

• 8–10+ years of relevant experience in a cGMP biopharmaceutical environment.
• Significant QA/validation, manufacturing sciences, or related functions experience.
• Experience with process validation and lifecycle management, including PPQ.
• Experience supporting technology transfer and manufacturing scale-up.
• Strong understanding of FDA/EMA/ICH/EU GMP requirements.

Responsibilities

• Serve as the External Quality SME for validation and technology transfer across BioMarin’s external manufacturing network.
• Act as the Quality lead for technology transfers to CMOs/CDMOs, establishing effective Quality partnerships and ensuring compliant transfer execution.
• Define and maintain Quality validation expectations and standards for externally manufactured products.
• Provide Quality oversight of validation lifecycle activities (process validation/PPQ, cleaning validation, equipment/facility qualification).
• Review and approve validation strategies, Master Plans, protocols, reports, risk assessments, and GMP documentation.
• Assess validation and technology transfer risks, identify gaps, and elevate significant risks to leadership.
• Provide oversight of technology transfer readiness, including CMO/CDMO capabilities and GMP readiness.
• Partner with Technical Development/Services and External Quality Operations to ensure development and implementation of process parameters and controls.
• Represent External QA Validation in governance forums and with external partners.

Skills

Quality Assurance

Validation

Technology Transfer

Cross-functional Leadership

Education

BS in Engineering/Life Sciences

Job description

BioMarin in Novato, CA is seeking a Manager/Sr. Manager, External QA Validation to lead quality oversight of process validation and technology transfer across BioMarin’s external manufacturing network.

You will partner with TDS, GEO, and PQL teams to ensure validated, compliant manufacturing and transfer readiness, while maintaining regulatory alignment with FDA/EMA expectations. Travel may be required.