Director, Quality Control

The Position

The Director, Quality Control, reporting to the Executive Director, Quality Operations, will oversee the External Quality Control department, managing release, stability, and IPC testing at contract manufacturers and laboratories for DNA, mRNA, gRNA, LNP, and lipids. We are seeking a collaborative, experienced people manager, with strong technical skills, GMP compliance experience, and exceptional communication skills to support a pipeline of gene editing products. This role is based at Verve's Boston headquarters and will require a minimum of three days onsite per week.

Job Responsibilities

• Responsible for the oversight of all QC activities at GMP vendors (eg, CMOs, test sites)
• Manage a team responsible for QC operations, method validation and technical transfer, and stability at CDMOs and contract laboratories
• Participate and represent QC on CMC teams such as supply chain/logistics processes, tech transfer, and analytical method and manufacturing process improvements
• Serve as the decision-maker and spokesperson for QC operational issues internally and externally
• Write, review, and approve GMP documentation (SOPs, protocols, technical reports, stability reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.)
• Oversee the QC aspects of the batch release process
• Provide QC oversight for the tech transfer of drug substance and drug product
• Partner with the internal QC team to align best practices and transfer methods to the internal lab
• Foster career development of the high-potential team, while planning for growth in alignment with the organization's evolving needs
• Prioritize, direct, and participate in continuous improvement initiatives
• Direct and provide guidance on laboratories investigations, deviations, change controls CAPAs and risk assessments
• Manage the review and approval of QC data, CoA/CoTs and other documentation
• Author, review and support regulatory submissions for multiple products and countries
• Manage material specifications for excipients, drug substances and drug products
• Partner cross-functionally (e.g., Analytical Development, Quality Assurance, Technical Operations, Process Development and Regulatory Affairs) to author QC SOPs, protocols, and reports
• Other duties as assigned

Qualifications

• B.S. in scientific field and 10+ years demonstrated quality experience in GMP environment or pharmaceutical/biopharmaceutical industry with 5+ years in QC laboratory management
• Experience working with CDMO labs and other external contract test labs including method transfer, qualification/validation, release testing, stability testing
• Experience with a broad range of mRNA and/or LNP analytical methods preferred
• Knowledgeable in cGMP including early and late phase appropriate method qualification, stability, laboratory investigations, and risk assessment from a technical and regulatory compliance perspective
• Experience authoring regulatory filings, to support early and late phase programs
• Strong written and verbal communication skills