Dyne Therapeutics

Develops muscle-disease therapies using FORCE platform

Director of Quality Assurance GMP Operations

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeWaltham, MA, USA$188k - $230k

About the Job

Requirements

A minimum of a BA/BS degree is required.
A minimum of 10 years of experience in GMP Quality Operations at a late-stage clinical and/or commercial biotechnology company is required.
Leadership experience managing cross-functional teams and influencing teams to prioritize activities and allocate resources without direct authority is required.
Experience implementing and utilizing various outsourcing and support models is required.
Experience disposing of product batches and interfacing with a Qualified Person is required.
Strong written and oral communication skills, including presentation skills, are required.
Organizational skills and the ability to manage multiple priorities are required.
Collaboration and interpersonal skills to interact effectively with internal and external stakeholders at all organizational levels are required.
General business management knowledge to assess the impact of project decisions on financial and corporate objectives is required.
The ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities is required.

Responsibilities

Manage external quality operations supporting clinical and commercial GMP manufacturing activities.
Manage deviation, out-of-specification, and out-of-trend investigations in accordance with current Good Manufacturing Practice principles and International Council for Harmonisation guidelines.
Review batch records, analytical method reports, technical reports, and regulatory sections of IND/IMPD and BLA/MAA submissions.
Provide Quality Assurance support for technology transfer and process validation activities.
Disposition GMP batches and interface with the Qualified Person.
Manage change control to ensure manufacturing- and testing-related changes are properly evaluated by Quality, Regulatory, and subject matter experts.
Manage contract development and manufacturing organization performance in accordance with Quality Agreement expectations and GMP compliance requirements.
Drive continuous improvement and inspection readiness.
Collaborate cross-functionally to complete pre-approval inspection and commercial-readiness activities at contract development and manufacturing organizations and internally.
Adjudicate compliance discussions and negotiate required corrective actions.
Foster collaboration and engagement to advance quality outcomes and operational excellence.

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 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 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.

MA Pay Range 188000 - 230000 USD

About the Company

Dyne Therapeutics

Develops muscle-disease therapies using FORCE platform

Dyne Therapeutics develops therapies for serious muscle diseases using its FORCE™ platform, which helps deliver oligonucleotide medicines to muscle tissue. Through a portfolio of experimental therapies, the company advances them in clinical trials (ACHIEVE and DELIVER) with the aim of treating rare muscle diseases. The product works by enhancing targeted delivery of oligonucleotides to muscle, enabling existing genetic medicines to reach affected tissues more effectively. Dyne differentiates itself by its proprietary FORCE™ technology and its focus on rare muscle diseases, positioning itself for growth as trials progress toward potential commercialization. The company’s goal is to bring effective treatments to patients and families affected by serious muscle diseases, expanding options as its therapies advance through development and, potentially, regulatory approval.

Company size: 201-500
Company stage: IPO
Headquarters: Waltham, MA
Founded: 2017

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