Director, QA GMP Operations at Dyne Therapeutics

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

24 Mar, 26

Salary

230000.0

Posted On

24 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Quality Operations, Leadership, Cross-Functional Team Management, Outsourcing Models, Batch Disposition, Communication Skills, Organizational Skills, Collaboration, Business Management, Timelines Management, Continuous Improvement, Inspection Readiness, Quality Compliance, Change Management, Technical Report Review, Process Validation

Industry

Biotechnology Research

Description

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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and 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 https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. Role Summary: The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance. The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview. This is an onsite role based in Waltham, MA. Primary Responsibilities Include: Management of external quality operations in support of GMP manufacturing (clinical and commercial) 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 support of Tech Transfer and Process Validation activities. Disposition of GMP batches and interfacing with the Qualified Person (QP). Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts. Manage CDMO performance within Quality Agreement expectations and GMP compliance. Drive continuous improvement and inspection readiness. Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally. Adjudicate on compliance 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 experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority Experience implementing and utilizing various outsourcing and support models Experience with disposition of product batches and interfacing with a Qualified Person (QP) Excellent written and oral communication skills, including well-developed presentation skills Excellent organizational skills and ability to manage multiple priorities Strong collaboration and interpersonal skills 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 drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities Embrace Dyne’s core values and culture #LI-Onsite MA Pay Range $188,000—$230,000 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.

Responsibilities

The Director of QA GMP Operations is responsible for managing GMP quality within external manufacturing operations and internal GMP operations. This includes oversight of QA activities, managing deviations, and ensuring compliance with quality deliverables.