Associate Director Clinical QA Compliance ensuring quality and integrity of clinical development activities at BioNTech. Leading the proactive, risk - based Quality Strategy implementation across clinical trials.
About the role
- Director of GMP Quality Assurance overseeing the Biologics manufacturing pipeline at Disc Medicine. Ensuring quality oversight and compliance for late-stage clinical trials across diverse teams.
Responsibilities
- Provide quality partnership and oversight of Disc Medicine’s Biologics manufacturing, testing, and disposition of products.
- Support ongoing technology transfer of drug product and device manufacturing processes.
- Ensure compliance in Disc Medicine Quality Management System and CDMO manufacturing and testing operations with applicable GMP regulations.
- Collaborate with cross-functional teams to draft, review, and verify documents to Health Authority CMC submissions.
- Develop, implement and approve risk-based quality system oversight related to CDMO manufacturing and testing of combination products.
- Partner closely with internal stakeholders to ensure program alignment and timely delivery of quality milestones.
- Identify and escalate quality risks while driving effective, compliant resolutions.
Requirements
- Bachelor’s Degree in a scientific discipline or related scientific field.
- 12-15 years of progressive Quality Assurance experience, with experience in Technology Transfer, Global Quality Management System design and implementation.
- Hands-on expertise with Combination Products (Device and Biologic) including the ability to develop business and QMS processes, procedures.
- Proven track record for building Quality culture with direct experience in supporting GMP operations.
- Proven track record for working on CMC, development program, quality management review, and vendor joint steering committees.
- Demonstrated experience in all aspects of clinical development of biologics is desirable; development of quality strategy and direct discussions with applicable Health Authorities.
- Self-driven, extraordinarily organized, and have an established track record for building effective working relationships across stakeholder groups.
- Ability to convey complex issues, risks, solutions, and decisions succinctly.
- Ability to travel nationally and internationally (10-20%)
Benefits
- Comprehensive benefits
- Competitive compensation packages
- Flexible work environment
Job title
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Not specified
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