Associate Director/Director, Quality Assurance, CMC

Responsibilities

• Provide QA oversight of CMO operations for cell banks, drug substance and drug product
• Ensure clinical manufacturing complies with cGMP and company policies
• Disposition cell banks, drug substance and finished product for clinical supply
• Work with external Qualified Person to ensure product suitability for release in EU
• Serve as QA lead for deviations, investigations, OOS results and change controls
• Lead or participate in risk assessments including FMEA
• Support GMP supplier audits, regulatory inspections and submissions

Requirements

• BS or MS in Biology, Chemistry, Engineering or related life sciences
• 10+ years in biotech or pharma with biologics, including 5+ years in QA oversight
• 5+ years managing quality relationships with CMOs
• 5+ years of batch disposition of GMP materials
• Strong knowledge of cGMP, 21 CFR 210/211, 600s, EU GMP Annex 1, ICH Q8-Q10
• Experience with quality systems, CAPA, change control and supplier management
• Experience authoring SOPs and reviewing analytical raw data
• Proven project management and communication skills

Preferred Qualifications

• Combination product or medical device experience, including 21 CFR Part 4 and ISO 13485
• 2+ years of GxP auditing experience
• Experience with electronic quality management systems such as Veeva

About the Company

• Clinical-stage biotech developing therapies for severe autoimmune diseases.