Sr. Technical Manager, CTO Quality Management & Operations

Key Responsibilities

• 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.
• 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.
• 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.
• 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.