Technical Manager / Sr. Technical Manager, CTO Quality Management & Operations

Role Summary

The Manager, CTO Quality Management & Operations is responsible for GMP Quality oversight of Contract Testing Organizations (CTOs) that perform testing of BioMarin intermediates, drug substance/API, and drug product across the legacy BioMarin and Amicus portfolios. The role ensures external testing activities are executed in compliance with approved methods, regulatory filings, Quality Technical Agreements (QTAs), and BioMarin policies and procedures, with particular focus on method transfers, release testing oversight, and quality issue resolution at assigned CTOs.

The incumbent acts as a key Quality point of contact for assigned external testing partners and plays a pivotal role in ensuring effective communication and streamlined processes for outsourced QC testing. They partner cross-functionally with Analytical Sciences, Regulatory Affairs, Supply Chain, Procurement, and Site Quality to ensure external testing models remain compliant, sustainable, and aligned with BioMarin's QC Network Strategy.

Key Responsibilities

CTO Oversight:

• Own day-to-day Quality oversight of assigned CTOs and ICT laboratories, ensuring external testing is performed in accordance with approved methods, QTAs, regulatory filings, and BioMarin requirements.
• Lead the Quality oversight strategy for assigned CTOs by assessing CTO health and developing risk-reduction and performance-improvement plans in partnership with CTOs.
• Lead and facilitate Quality Review Meetings (QRMs) and ongoing performance monitoring with assigned external laboratories.

Method Transfer & Lifecycle Management:

• Project manage the transfer of analytical methods into CTOs and ICT labs, liaising internally with SMEs across Analytical Sciences, QC, and Regulatory.
• Support method validation, verification, and lifecycle management activities at external and in-country testing laboratories.
• Support in-country testing requirements, including the set-up of in-country central labs and registration testing as required for market launches.

Quality Systems & Compliance

• Lead and/or support GMP quality system activities related to external testing, including deviations, investigations, CAPAs, change controls, quality risk assessments, and product complaints.
• Own, maintain, and administer Quality Technical Agreements (QTAs) and support alignment of GMP roles and responsibilities with external testing partners.
• Partner with BioMarin Global Compliance & Ethics (GCE) to schedule compliance audits and resolve compliance gaps identified, including those from health authority inspections.
• Ensure inspection readiness through oversight of compliant documentation, timely response to audit findings, and verification of corrective actions associated with external testing partners.

Cross Functional & Network Support

• Serve as a Quality representative on cross-functional teams, providing GMP guidance to ensure quality considerations are incorporated into decisions impacting external testing.
• Provide GMP Quality oversight for the integration of new QC workstreams, including those associated with new products, acquisitions, or changes to the external testing network.
• Provide Quality input to budget, Annual Operating Plan (AOP), and forecast activities related to external testing.

Qualifications

• Bachelor's degree in a scientific or engineering discipline (Chemistry, Biology, Pharmaceutical Sciences, or related). Advanced degree preferred.
• Minimum 6+ years of GMP Quality experience in pharmaceutical or biotech, with demonstrated experience overseeing contract laboratories or external QC operations.
• Working knowledge of US (FDA) and European (EMA) GMP regulatory requirements, guidelines, and expectations; additional jurisdictions (e.g., PMDA, ANVISA, NMPA) a plus.
• Strong understanding of analytical method transfer, validation, and QC release testing for drug substance and drug product.
• Experience with QTAs, deviations/CAPA, change control, and quality risk management.
• Strong project management and stakeholder communication skills; able to manage multiple CTO relationships and competing priorities.
• Inspection-readiness mindset: values clear documentation, evidence-based decision-making, and rigorous due diligence.
• Collaborative and cross-functionally oriented; able to influence without authority across Quality, Analytical Sciences, Regulatory, Supply, and Procurement.
• Demonstrated ability to operate independently in a remote/hybrid environment with global stakeholders.

Approximately 10–20% domestic and international travel to CTOs, ICT partners, and BioMarin sites as required.

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.

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.