remote
Vice President, Head of Quality Assurance - Treeline Biosciences
Software Engineer
Seeking a Vice President, Head of Quality Assurance to provide strategic and operational oversight for drug development, manufacturing, and commercialization. This role focuses on developing and implementing robust quality systems.
About the role
Key Responsibilities
- Provide strategic and operational quality assurance oversight for manufacturing, clinical operations, pharmacovigilance, and external partner activities.
- Lead the development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks.
- Support clinical development, inspection readiness, manufacturing scale-up, and commercialization activities.
- Manage commercial product lifecycle management.
- Collaborate cross-functionally with CMC and other departments.
- Ensure compliance with regulatory requirements and industry best practices.
Requirements
- Extensive experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Proven track record in leading quality systems development and implementation.
- Strong understanding of drug development lifecycle, from clinical trials to commercialization.
- Experience with regulatory inspections and compliance.
- Excellent leadership and cross-functional collaboration skills.
Skills
software developmentsystem designproblem solving