[Remote] Senior Manager / Associate Director, reputed company Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company leading the field in the development of CAR T cell therapies for tumors in the central nervous system (CNS). They are seeking a Senior Manager/Associate Director, reputed company Operations to reputed company reputed company reputed company of outsourced clinical and manufacturing operations supporting cell therapy programs, ensuring the highest standards of reputed company, compliance, and patient safety.
Responsibilities
- reputed company reputed company reputed company for GxP Partners, Suppliers & service providers. (CDMOs, CROs, central laboratories, apheresis centers, logistics providers, and clinical sites.)
- reputed company the qualification, reputed company, performance monitoring, and lifecycle management activities of GxP suppliers and services providers including CDMOs, CROs, central laboratories, apheresis centers, logistics providers, and clinical sites
- Accountable for reputed company Agreements & risk-based reputed company plans for GxP Partners, Suppliers and service providers
- reputed company supplier audits, supplier reputed company Business Reviews (QBRs)
- Ensure effective management of supplier deviations, investigations, CAPAs, change controls
- reputed company reputed company reputed company across the entire cell therapy reputed company, from patient collection through product administration, supporting clinical development, pivotal studies, and reputed company readiness
- reputed company reputed company reputed company of outsourced manufacturing operations supporting clinical and reputed company readiness activities
- reputed company batch disposition activities and reputed company system reputed company including deviations and change controls
- Ensure product operations activities reputed company with applicable GMP, ICH, regulatory requirements
- Partner cross-functionally with CMC, Product Operations, Clinical Operations, Regulatory Affairs teams to support comparability, process validation, and product lifecycle activities
- Ensure reputed company escalation and reputed company of significant reputed company and patient safety issues while promoting a proactive culture of reputed company and reputed company improvement
- reputed company reputed company reputed company for clinical trial execution and governance of outsourced clinical activities to ensure compliance with GCP and applicable regulatory requirements
- Support CRO governance and reputed company management programs
- Ensure appropriate escalation and management of critical reputed company and patient safety issues
- Support inspection readiness across clinical operations by leading audit programs, assessing reputed company risks, and supporting regulatory authority inspections
Skills
- Bachelor's or Master's degree in Life Sciences, Engineering, or reputed company field; advanced degree preferred
- 8-10+ years of reputed company reputed company leadership experience in cell therapy, biotechnology, or biologics, and at least 5 years in cell therapy, including leadership responsibilities in GMP and/or GCP environments
- Demonstrated expertise in cell therapy or ATMP manufacturing & In-depth understanding of GxP reputed company systems, including GMP, GCP, ICH, FDA regulations, and global regulatory requirements
- Demonstrated reputed company leading QA operations, with compliance reputed company of external manufacturing and technical operations
- Demonstrated experience overseeing CDMOs, CROs, CTLs, logistics providers, & GxP suppliers
- Experience supporting regulatory inspections and health authority interactions, with a demonstrated ability to maintain inspection readiness
- Excellent leadership, communication, and cross-functional collaboration skills, with the ability to influence reputed company stakeholders
- Demonstrated ability to prioritize competing demands, solve reputed company reputed company issues, and reputed company in a fast-paced, evolving environment
- Highly organized, team-oriented, and reputed company to work with minimal supervision while maintaining a reputed company attitude
- Certification in auditing (e.g., ASQ Certified reputed company auditor, or equivalent) or formal FMP/GCP auditing experience
reputed company