Our commitment to people with muscle diseases
is our greatest strength

Associate Director, Quality Assurance Operations

Department: 110 CMC

Location: Waltham, MA

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The Associate Director of QA Operations will be the QA technical lead on external manufacturing project teams and responsible to develop, establish, and maintain Quality Systems, Procedures, Policies and Metrics that support external manufacturing activities and Product release to the clinic. This role will provide leadership for all quality operation activities and proactively assess compliance issues and risks serving as the expert GMP consultant for issue management & issue escalation, with a focus on critical and major quality events. The Associate Director of QA Operations will participate in the development of functional strategic plans to support organizational goals and provide guidance to functional areas concerning quality operations.

This role will report to the Senior Director of Quality Assurance and will work closely with key stakeholders including CMC, Regulatory Affairs, and Project Management.

This role is based in Waltham, MA without the possibility of being a remote role.

Primary Responsibilities Include:

  • Oversee release activities for DSI, DS, and DP including batch record review/release activities. Represent Quality Operation at CMO meetings.
  • Ensure that contract manufacturing activities are aligned with current regulatory requirements, standards and industry trends.
  • Provide the framework for the for review of batch records and ensure that any compliance issues are addressed in a timely manner.
  • Lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness.
  • Support change management actions that directly impact manufacturing.
  • Provides input to for DSI, DS, and DP specifications, stability protocols, and product labeling as needed.
  • Support on-site internal auditing program by assisting with audits when required.
  • Participate in domestic and international audits of CMO sites
  • Develops or monitors metrics (KPI’s) for all Quality Operations regarding Management Review
  • Provide QA operations training to teammates.
  • Support investigational new drug applications and related correspondence from global regulatory authorities

Education and Skills Requirements:

  • Bachelor’s Degree in Engineering, Science, Business or Business Management, or Quality Systems Management is required. Graduate degree preferred but not required.
  • Minimum of 8 years of related work experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry.
  • 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 area would be beneficial
  • Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources. Consistently delivers
  • 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 al QA activities when required.

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.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

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.


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