Director of Quality Assurance

Reports to: CEO | Location: CA (100% onsite)

CDC are proud to be working with a globally recognised, leading CDMO specialising in synthetic peptide and oligonucleotide production, with one of the largest research peptide facilities in the world. They're building a new greenfield peptide manufacturing site and need a QA Director to build the entire quality function from the ground up - reporting directly to the CEO and owning quality strategy, systems, and compliance through commercial launch (targeting Q4 2026).

Key Responsibilities

• Develop the site's medium and long-term quality roadmap, KPIs, and budget
• Establish a site-wide, compliance-first quality culture from scratch
• Own full site compliance with FDA 21 CFR 210/211, ICH Q7/Q9/Q10, EU GMP, USP/EP
• Serve as primary QA contact for all FDA, EMA, and client audits
• Provide full QA oversight of peptide synthesis, purification, fill-finish, and packaging
• Hold batch release authority for peptide DS/DP and intermediates
• Build the QMS and document control function from the ground up - SOPs, batch records, validation documentation, electronic systems, archive infrastructure
• Enforce ALCOA+ data integrity across the site
• Implement an ICH Q9-aligned risk framework
• Govern deviations, OOS/OOT, and CAPA closure
• Run internal mock audits ahead of regulatory inspections
• Design and build the QA organisation - document control, compliance/audit, batch release, QMS specialists
• Develop a local quality talent pipeline

Qualifications

• Master's degree or higher in Pharmacy, Pharmaceutical Engineering, Chemistry, Biopharmaceutics, or related field (MS/PhD in Pharmaceutical, Organic, or Analytical Chemistry preferred)
• 5+ years of QA experience in a peptide/pharmaceutical CDMO
• 4+ years managing a QA team, ideally with direct document control oversight
• Deep working knowledge of FDA 21 CFR 210/211, ICH Q7/Q9/Q10, EU GMP, USP/EP
• Direct experience leading FDA/EU regulatory inspections and client CDMO audits
• Greenfield site experience building QMS/document systems strongly preferred
• Domestic travel up to 10%; valid passport required, occasional international travel possible