Sobre esta vaga de Associate Director, GMP QA Operations na Dyne Therapeutics
Company Overview:
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
This position is based in Waltham, MA.
Primary Responsibilities Include:
- 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
Education and Skills 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.
- 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
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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.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
