Executive Director, Quality Assurance

The Position

Verve is seeking an Executive Director, Quality Assurance to lead all aspects of GMP Quality Assurance. The role involves continued development, implementation, and maintenance of a comprehensive GxP Quality Management System to support all aspects of drug development and manufacturing from preclinical to phase 1 and beyond.

This individual will be responsible for the vendor quality oversight of GMP production and testing of materials and drug product for clinical stage development at external manufacturing sites (CDMOs) and contract testing labs (CTLs) as well as QA oversight of the Verve GxP QC laboratory. This role is hybrid, with the expectation that the selected candidate will be able to come into the office on a regular basis.

Job Responsibilities

• Provide leadership and oversight for GxP QA including:
• Development and implementation of a phase-appropriate Quality Management System, including SOPs, change control, investigations, CAPA, compliance, document management, training management and validation
• Quality Operations function responsible for disposition of GMP materials and products based on review of batch records, test records, regulatory filings, GMP requirements and other Verve requirements
• Vendor qualifications and external/internal audits and regulatory inspections
• QA support for Verve GxP QC laboratory operations
• Manage budget and resources to address strategic needs of QA, including hiring decisions, talent management, and mentoring/development of QA team members
• Establish and implement SOPs and phase-appropriate quality-related systems and standards to maintain compliance with FDA, ICH, EU, and other country-specific regulations including GxP practices
• Identify and address gaps or areas for improvement in systems, procedures, and quality initiatives
• Collaborate with Verve Manufacturing, QC and Process Development and R&D on issues such as review and approval of batch records, certificates of analysis/testing and compliance, in-process and release test methods, specifications, stability protocols/reports, analytical method validations, technical study reports, trending reports, etc.
• Support review of regulatory filing activities, as needed
• Establish and maintain Quality Technical Agreements with CDMOs and CTLs
• Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at CDMOs and CTLs
• Maintain a Quality Risk Management system to identify and mitigate compliance risks
• Other responsibilities as assigned

Qualifications

• BA/BS in scientific discipline with an advanced degree preferred
• 15+ years demonstrated GMP quality experience in the pharmaceutical/ biopharmaceutical industry
• Experienced with drug development for complex biologics
• Experience interacting with CDMOs, QPs, and relevant regulatory authorities
• Experience with review of regulatory requirements and filings
• Strong interpersonal and communication skills (written and verbal), team player, with good decision-making ability that is results oriented without compromising quality
• Demonstrated project management and organizational skills
• Strong aptitude with Microsoft Office applications (Word,Excel, etc.)
• Ability to travel, as needed