Vice President of Quality Assurance and Compliance
Job Title:
Vice President of Quality Assurance and Compliance
Location:
San Diego, CA, USA
Industry:
Biotechnology
Summary:
ProGen Search is partnering with a leading biotechnology company specializing in cell and gene therapies in search of a Vice President of Quality Assurance and Compliance. This executive role ensures that the organization’s quality systems meet regulatory standards and support the development of innovative cell and gene therapies.
Responsibilities:
- Develop and maintain quality systems to comply with FDA, EMA, and other regulatory standards.
- Oversee quality assurance activities for preclinical, clinical, and commercial operations.
- Lead regulatory inspections and audits.
- Establish and monitor KPIs for quality performance.
- Collaborate with cross-functional teams to integrate quality systems into all areas of the business.
- Provide strategic guidance on compliance matters to executive leadership.
Qualifications:
- Bachelor’s degree in life sciences or a related field; advanced degree preferred.
- 15+ years of quality assurance experience in biotechnology or pharmaceuticals.
- Strong knowledge of cGMP, GLP, and GCP regulations.
- Exceptional leadership and problem-solving skills.
- Proven success in managing regulatory inspections.
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