External QA Validation Lead – Tech Transfer & GMP

BioSpace; Novato (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

BioMarin seeks a Manager/Sr. Manager, External QA Validation to lead quality oversight for process validation and technology transfer across the external manufacturing network.

You will set validation standards, review GMP documentation, and partner with CMOs/CDMOs to ensure compliant transfers and scalable manufacturing. You will oversee risk assessments, transfer readiness, and cross-functional collaboration with TDS, GEO, and PQL teams to maintain BioMarin standards and regulatory

Qualifications

• BS in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related technical discipline with 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 FDA/EMA/ICH/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.
• Define and maintain Quality validation expectations and standards for externally manufactured products in alignment with BioMarin Global Policies and regulatory requirements.
• Provide Quality oversight of validation lifecycle activities, including process validation/PPQ, cleaning validation, equipment and facility qualification.
• Review and approve validation strategies, Validation Master Plans, protocols, reports, risk assessments, and other GMP documentation.
• Assess validation and technology transfer risks, identify gaps, recommend mitigation strategies, and escalate significant risks to Technology Transfer Lead and Quality leadership.
• Provide Quality oversight of technology transfer readiness, including assessment of CMO/CDMO capabilities and GMP readiness.
• Partner with Technical Development and Services and Global Quality to ensure development and implementation of process parameters and controls strategies.
• Represent External QA Validation in governance and technical forums supporting transfer and external manufacturing.
• Maintain current knowledge of evolving industry standards and regulatory requirements for biologics manufacturing.
• Influence decisions across internal and external organizations without direct authority, building strong partnerships with CMOs/CDMOs.
• Other duties as assigned. Periodic travel is required.

Skills

Technical leadership

Quality leadership

Cross-functional collaboration

Communication skills

Education

BS in Engineering or Life Sciences

Job description

BioMarin seeks a Manager/Sr. Manager, External QA Validation to lead quality oversight for process validation and technology transfer across the external manufacturing network.

You will set validation standards, review GMP documentation, and partner with CMOs/CDMOs to ensure compliant transfers and scalable manufacturing. You will oversee risk assessments, transfer readiness, and cross-functional collaboration with TDS, GEO, and PQL teams to maintain BioMarin standards and regulatory