VP, Pharmaceutical Quality

Role Summary

The VP, Pharmaceutical Quality is the functional head of product quality for the company, overseeing quality assurance and quality control, and managing the total cGMP compliance function. This individual will be responsible for ensuring compliance with established company cGMP quality policies, practices, standard operating procedures (SOPs) and federal regulations. Managing and overseeing quality assurance and quality control at external vendors, auditing manufacturing, testing and supply sites, and providing support for regulatory filings and inspections. This role is based in Waltham, MA and is not fully remote.

Responsibilities

• Design, implement and maintain cGMP QA and QC programs, and the compliance infrastructure. This includes the cGMP-related SOP system, training programs, and performing internal and external audits
• Work with the company's external suppliers including clinical manufacturing organizations (CMOs) and contract labs to ensure consistent cGMP quality and compliance
• Direct development and implementation of cGMP quality systems to ensure product reliability, quality, efficacy, compliance with applicable SOPs, cGMP regulations; phase-appropriate quality systems and approach
• Lead resolution of product complaint, OOS and OOT investigations in phase-appropriate manner; lead and manage Material Review Board (MRB)
• Lead setting up and managing stability program for pre-commercial and commercial products; data analyses and stability sections of regulatory filings
• Oversee cGMP compliant auditing program to fulfill regulatory requirements
• Develop, manage and monitor adherence to the overall Quality and Compliance at Dyne
• Develop, analyze and report business metrics and highlights; manage department budget
• Manage inspections by the FDA, other regulatory agencies and commercial partners at CMOs
• Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements
• Manage and build a team suitable for the growing needs of the organization

Qualifications

• Bachelor's degree in science or a related field; advanced degree strongly preferred
• 15+ years' experience in the pharmaceutical or biotechnology industry in cGMP quality and compliance role
• 5+ years' experience as a functional head of a quality department
• Strong cGMP knowledge in the pharmaceutical industry and implementing a phase-appropriate cGMP quality system
• Hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)
• Proven record of developing and maintaining successful working relationships with regulatory agencies
• Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing
• Strong experience and knowledge of cGMP manufacturing and stability to support BLAs/NDAs
• Strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments
• Ability to work, influence, and gain consensus across multiple functions (CMC, R&D, and Regulatory Affairs)
• Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, including IND, BLA, and post-approval changes
• Strong analytical, problem solving and critical thinking skills
• Excellent interpersonal, verbal, and written communication skills with the ability to work in strong cross-functional relationships and communicate complex issues enterprise-wide, from the executive team to the manufacturing floor
• Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors