Role Summary:

The Senior Manager, GMP QA Operations oversees quality activities associated with contract manufacturing organizations (CMOs) and ensures compliance with FDA and global GMP regulations. Leads tactical GMP QA operations supporting manufacturing, testing, deviation investigations, and CAPA implementation to enable compliant product disposition for clinical development and future commercialization. Partners cross-functionally to ensure quality systems are effectively applied and continuously improved to support Dyne Therapeutics' pipeline.

This is an onsite role based in Waltham, MA.

Primary Responsibilities Include:

Quality Operations Execution

• Oversees release activities for Drug Substance (DS) and Drug Product (DP), including batch record review and disposition decisions
• Assembles product disposition packages and Certificates of Conformance to support clinical trial supply and commercialization readiness
• Ensures timely and compliant execution of GMP QA activities across manufacturing and testing operations

External Manufacturing Oversight (CMOs)

• Represents GMP QA in interactions with CMOs, including governance meetings and operational discussions
• Ensures contract manufacturing activities align with applicable regulatory requirements, industry standards, and internal expectations
• Monitors vendor quality performance through defined metrics and ensures adherence to GMP requirements

Quality Systems & Compliance

• Leads and supports GMP investigations, including root cause analysis, CAPA development, tracking, and effectiveness verification
• Partners with internal teams to support change management activities impacting manufacturing and testing
• Works within and enhances internal processes for batch record review and quality event management to ensure timely resolution of compliance issues
• Develops and tracks Quality Operations metrics (KPIs) for Management Review

Cross-Functional Collaboration & Continuous Improvement

• Collaborates with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and Project Management to ensure alignment on quality objectives
• Partners with Quality Management Systems teams to drive consistency and continuous improvement across quality processes
• Communicates quality risks, issues, and trends clearly to stakeholders to support informed decision-making

Education and Skills Requirements:

• Bachelor's degree in Engineering, Science, or relevant discipline; or Master's Degree preferred
• 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.
• A working knowledge of the therapeutic industry would be beneficial.
• 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.
• Proficiency with software applications such as MS Office, SmartSheet, Veeva a plus

#LI-Onsite

MA Pay Range

$160,000-$195,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.