Associate Director, GMP QA Operations

Dyne Therapeutics•Waltham, MA

2d•Onsite

About The Position

The Associate Director, QA Operations serves as the QA technical lead for external manufacturing and testing project teams, ensuring the effective development, implementation, and continuous improvement of Quality Systems, procedures, policies, and metrics supporting GMP activities. Provides leadership across QA operations while proactively identifying and mitigating compliance risks and serving as a subject matter expert for complex quality issues and escalations. Contributes to functional strategy and partners cross-functionally to ensure quality excellence across development and manufacturing activities.

Requirements

Bachelor’s degree in Engineering, Science, or relevant discipline; or Master’s Degree preferred
8+ years’ experience in related cGMP environment (e.g., Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry)
5+ 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.
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.

Nice To Haves

A working knowledge of the therapeutic industry would be beneficial.
Flexible and creative problem-solving skills; ability to challenge current processes, practices, and strategy and uncover alternative approaches, solutions, or methods.
Proficiency with software applications such as MS Office, SmartSheet, Veeva a plus

Responsibilities

Serves as QA lead for external manufacturing and testing teams, providing technical guidance and quality oversight
Represents QA Operations in interactions with CMOs and external partners
Ensures contract manufacturing activities align with current regulatory requirements, standards, and industry best practices
Participates in CMO Quality Agreement review and management
Oversees release activities for Drug Substance Intermediates (DSI), Drug Substance (DS), and Drug Product (DP), including batch record review and disposition decisions
Leads or supports investigations into significant quality issues, driving root cause analysis and CAPA development, tracking, and effectiveness verification
Supports change management activities impacting manufacturing and testing
Provides input into specifications, stability protocols, and product labeling as needed
Supports regulatory submissions, including investigational new drug applications and related correspondence
Develops, implements, and maintains Quality Systems, procedures, policies, and metrics supporting GMP operations
Drives improvements to batch record review processes and ensures timely resolution of compliance issues
Manages CMO documentation and ensures accessibility of quality records
Develops and monitors Quality Operations metrics (KPIs) for Management Review
Participates in domestic and international audits of CMO sites and supports internal audit programs
Collaborates with CMC, Regulatory Affairs, and Project Management to align quality objectives and execution
Provides QA Operations training and mentorship to team members
Communicates quality risks and issues effectively to stakeholders to support informed decision-making