Note: The job is a remote job and is open to candidates in USA. BioMarin Pharmaceutical Inc. is a leading rare disease biotechnology company focused on genetically defined conditions. The Manager, CTO Quality Management & Operations is responsible for GMP Quality oversight of Contract Testing Organizations, ensuring compliance with approved methods and regulatory standards while facilitating effective communication and quality assurance across cross-functional teams.
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
Skills
- Bachelor's degree in a scientific or engineering discipline (Chemistry, Biology, Pharmaceutical Sciences, or related)
- 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
- 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
- Advanced degree preferred
- Additional jurisdictions (e.g., PMDA, ANVISA, NMPA) a plus
Benefits
- Approximately 10–20% domestic and international travel to CTOs, ICT partners, and BioMarin sites as required.
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