Senior Manager, External QA Validation

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

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.

Manager/Sr. Manager, External QA Validation

Role Overview

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.

Key Responsibilities

• Serve as the External Quality technical SME for validation and technology transfer, providing Quality leadership and oversight 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 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 escrow 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.

Experience/Education

• 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 includes other duties as 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.