Director, QA GMP 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 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 and follow us on X LinkedInand Facebook.

Role Summary:

The Director ofQA GMPOperationsis responsibleformanagementofGMP quality within ourexternalmanufacturing operationsgloballyand internal GMP operationsfor development and Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomesto advance programs within Directoris responsible foroversight ofQAactivitiesandensuring the quality of deliverables within the roles purview.

This is an onsite role based in Waltham MA.

Primary ResponsibilitiesInclude:

• Management ofexternal quality operations in support of GMP manufacturing (clinicalandcommercial) activities.
• Manage deviations OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines.
• Review batch records analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs.
• QA supportofTech Transfer and Process Validation activities.
• Disposition ofGMPbatchesand interfacing with the Qualified Person (QP).
• Changemanagement to ensure proper evaluation ofmanufacturing and testingrelated changesbyQuality Regulatory and Subject Matter Experts.
• ManageCDMO performancewithinQuality Agreement expectationsand GMP compliance.
• Drivecontinuousimprovementandinspectionreadiness.
• Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activitiesarecompletedat the CDMOsand internally.
• Adjudicate oncompliance discussions and negotiate any required corrective actions.
• Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence.

Education and Skills Requirements:

• Minimum of a BA/BS degree
• Minimum of 10 years of experiencein GMP Quality Operationsin aclinical late stage and/or commercial biotechnologycompany
• Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities andallocateresourceswithout direct authority
• Experience implementing andutilizingvarious outsourcing and support models
• Experience withdisposition ofproduct batches and interfacing with aQualified Person(QP)
• Excellent written and oral communication skills including well-developed presentation skills
• Excellent organizational skillsandability to manage multiple priorities
• Strong collaborationand interpersonalskills to effectively interact with internal or external stakeholders at all levels in the organization
• General business management knowledge to assess the impact of project decisions on financial and corporate objectives
• Ability to drivetimelines meet firmdeadlinesand adapt quickly to changing requirements and priorities
• Embrace Dynes core values and culture

#LI-Onsite

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.