Current Job Listings
Contract, interim, and permanent quality and regulatory roles at leading pharma, biotech, and CDMO organizations.
6 positions found
Director of Quality Assurance
Overview
Leading commercial-stage biotech seeks an experienced Director of Quality Assurance to own the site QMS, lead regulatory inspections, and build a high-performing QA team. This role reports to the VP of Quality and has direct oversight of QA operations for drug product manufacturing.
Responsibilities
- Own and continuously improve the site quality management system aligned with 21 CFR Part 211 and ICH Q10
- Lead preparation and execution of FDA pre-approval and routine surveillance inspections
- Manage CAPA, change control, deviation, and batch disposition programs
- Partner with manufacturing, regulatory affairs, and supply chain on quality-related decisions
- Develop and mentor a team of QA managers and specialists
Requirements
- 10+ years of QA experience in pharmaceutical or biotech manufacturing
- Direct experience leading FDA inspections as the primary quality representative
- Strong working knowledge of 21 CFR Part 211 and ICH Q10
- Experience with drug product (sterile or solid oral dosage) manufacturing environments
- BS/MS in a life sciences discipline; advanced degree preferred
Skills & Keywords
Interested in this role? Submit your profile and a placement specialist will be in touch.
Director of Quality Assurance
Overview
Leading commercial-stage biotech seeks an experienced Director of Quality Assurance to own the site QMS, lead regulatory inspections, and build a high-performing QA team. This role reports to the VP of Quality and has direct oversight of QA operations for drug product manufacturing.
Responsibilities
- Own and continuously improve the site quality management system aligned with 21 CFR Part 211 and ICH Q10
- Lead preparation and execution of FDA pre-approval and routine surveillance inspections
- Manage CAPA, change control, deviation, and batch disposition programs
- Partner with manufacturing, regulatory affairs, and supply chain on quality-related decisions
- Develop and mentor a team of QA managers and specialists
Requirements
- 10+ years of QA experience in pharmaceutical or biotech manufacturing
- Direct experience leading FDA inspections as the primary quality representative
- Strong working knowledge of 21 CFR Part 211 and ICH Q10
- Experience with drug product (sterile or solid oral dosage) manufacturing environments
- BS/MS in a life sciences discipline; advanced degree preferred
Skills & Keywords
Interested in this role? Submit your profile and a placement specialist will be in touch.
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