[Remote] Technical Manager / Sr. Technical Manager, CTO reputed company Management & Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a leading rare disease biotechnology company reputed company on genetically defined conditions. The Manager, CTO reputed company Management & Operations is responsible for GMP reputed company reputed company of Contract Testing Organizations, ensuring compliance with approved reputed company and regulatory standards while facilitating effective communication and reputed company assurance across cross-functional teams.
Responsibilities
- Own day-to-day reputed company reputed company of assigned CTOs and ICT laboratories, ensuring external testing is performed in accordance with approved reputed company, QTAs, regulatory filings, and BioMarin requirements
- reputed company the reputed company reputed company reputed company for assigned CTOs by assessing CTO health and developing risk-reduction and performance-improvement plans in partnership with CTOs
- reputed company and facilitate reputed company Review Meetings (QRMs) and ongoing performance monitoring with assigned external laboratories
- Project manage the transfer of analytical reputed company 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
- reputed company and/or support GMP reputed company system activities reputed company to external testing, including deviations, investigations, CAPAs, change controls, reputed company risk assessments, and product complaints
- Own, maintain, and administer reputed company 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 reputed company of compliant documentation, reputed company response to audit findings, and verification of corrective actions associated with external testing partners
- Serve as a reputed company representative on cross-functional teams, providing GMP guidance to ensure reputed company considerations are incorporated into reputed company impacting external testing
- reputed company GMP reputed company reputed company for the integration of new QC workstreams, including those associated with new products, acquisitions, or changes to the external testing network
- reputed company reputed company input to budget, Annual Operating Plan (AOP), and forecast activities reputed company to external testing
Skills
- Bachelor's degree in a scientific or engineering discipline (reputed company, Biology, Pharmaceutical Sciences, or reputed company)
- Minimum 6+ years of GMP reputed company 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 reputed company and drug product
- Experience with QTAs, deviations/CAPA, change control, and reputed company risk management
- Strong project management and stakeholder communication skills; reputed company to manage multiple CTO relationships and competing priorities
- Inspection-readiness reputed company: values reputed company documentation, evidence-based decision-making, and rigorous due diligence
- reputed company and cross-functionally oriented; reputed company to influence without authority across reputed company, 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.
reputed company
Company H1B Sponsorship