Senior Manager, GMP QA Operations
$160,000–$195,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Oversee release activities for Drug Substance and Drug Product, including batch record review and disposition decisions, while assembling product disposition packages and Certificates of Conformance. Ensure timely and compliant execution of GMP QA activities across manufacturing and testing operations, representing the team in CMO governance meetings and monitoring vendor quality performance. Lead deviation investigations, root cause analysis, and CAPA development, partnering with internal teams on change management and quality event resolution. Develop and track Quality Operations metrics for Management Review and communicate quality risks clearly to stakeholders. This onsite role in Waltham, MA, supports Dyne Therapeutics' clinical programs for Duchenne muscular dystrophy and myotonic dystrophy type 1.
Required Qualifications
- Bachelor's degree in Engineering, Science, or relevant discipline
- 6+ years' experience in related cGMP environment (e.g., Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry)
- 4+ years of related work experience in Quality Assurance or closely related role within Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry
- preferably with experience overseeing CMO/CDMO organizations
- Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations
- A proven track record of demonstrating good judgement & decision-making experience
- Excellent organizational skills
- Ability to concisely present quality events and the criticality to internal stakeholders
- Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues
- Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA
- Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources
- Flexible and creative problem-solving skills; ability to challenge current processes, practices, and strategy and uncover alternative approaches, solutions, or methods
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is enthusiastic and willing to jump in to meet to all QA activities when required
Desired Qualifications
- Master's Degree preferred
- A working knowledge of the therapeutic industry would be beneficial
- Proficiency with software applications such as MS Office, SmartSheet, Veeva a plus
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.