Description

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 escalate 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 include other duties as assumed or assigned.

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.