Senior Manager, GMP QA Operations

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 is an onsite role based in Waltham MA.

Primary ResponsibilitiesInclude:

Education and Skills Requirements:

• Bachelors degree in Engineering Science or relevant discipline; or Masters 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 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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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.