Dyne Therapeutics · 10 hours ago
VP, Pharmaceutical Quality
Waltham, MA
Full-time
Onsite
Director/Executive
$264K/yr - $330K/yr
15+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The VP, Pharmaceutical Quality will oversee quality assurance and quality control, ensuring compliance with cGMP regulations and managing quality at external vendors, while supporting regulatory filings and inspections.
BiotechnologyHealth CareMedicalPharmaceutical
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 complaint 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
Qualification
Required
Bachelor's degree in science or a related field
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
Preferred
advanced degree strongly preferred
Company
Dyne Therapeutics
Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
51-200 employees
H1B Sponsorship
Dyne Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (1)
2022 (3)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Hercules CapitalAtlas Venture
2025-12-09Post Ipo Equity· $402.5M
2025-06-30Post Ipo Equity· $230M
2025-06-30Post Ipo Debt· $100M
Leadership Team
John Cox
Chief Executive Officer
Recent News
2025-12-24
MarketScreener
2025-12-24
2025-12-24
Company data provided by crunchbase