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 within Dyne's quality management system including 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.

Responsibilities

• Design, implement and maintain cGMP QA Operations and QC programs, and compliance, including cGMP-related processes, training programs, and performing external audits within the Dyne quality management system
• 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 complaints and recalls, 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
• Partner with QMS team on cGMP compliant auditing program to fulfill regulatory requirements
• Develop, manage and monitor adherence to the overall cGMP Quality and Compliance at Dyne
• Proactively identify Quality risks and improvement opportunities across all stages of manufacturing in support of commercialization and work with stakeholders to mitigate risks
• Champion a consistent approach to Quality and compliance standards as they relate to product, recognizing the wider implications of Quality-related issues, including the implementation of the principles of Quality by Design and new and emerging regulatory guidance
• Support Regulatory filings and post-approval changes as well as lifecycle management to mitigate risks for successful outcomes
• 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

Education

• Bachelor's degree in science or a related field; advanced degree strongly preferred

Qualifications

• 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
• Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors