Associate Director, GMP QA Operations
Job Location:
Waltham, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) Pompe disease and multiple DMD mutations. At Dyne we are on a mission to deliver functional improvement for individuals families and communities. Learn more at and follow us onXLinkedInandFacebook.
Role Summary:
This position is based in Waltham MA.
Primary ResponsibilitiesInclude:
- 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:
- Bachelors degree in Engineering Science or relevant discipline; or Masters 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 andeffectively 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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MA Pay Range
$175000 - $200000 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.
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.
Required Experience:
Director
About Company
Repairing muscle, reclaiming now. Life-transforming therapies for inherited muscle diseases.
