We are seeking an experienced Quality leader to oversee all aspects of Quality Assurance, Quality Control, and compliance across clinical and commercial programs. This role reports to the executive team and will be responsible for shaping the company’s quality strategy, ensuring regulatory compliance, and driving a culture of quality throughout the organization.
Key Responsibilities:
- Lead and grow the quality function, including QA, QC, clinical quality, and supplier quality.
- Maintain and improve the Quality Management System in alignment with global regulations (GxPs, cGMP, GDP).
- Oversee product release, inspections, and lifecycle activities (changes, submissions, labeling).
- Manage relationships with external partners and ensure inspection readiness.
- Build, mentor, and develop a team of quality professionals.
Qualifications:
- 15+ years of quality leadership experience in biotech or pharma.
- Background in both clinical development and commercial manufacturing.
- Strong knowledge of US and international regulatory standards.
- Track record of successful product launch and lifecycle quality management.
- Ability to lead in a lean, collaborative environment with strong communication and decision-making skills.
