Our commitment to people with muscle diseases
is our greatest strength

Senior Manager, Quality Systems

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 Senior Manager of Quality Systems will be the QA lead to develop and maintain Dyne Quality Systems. This role will provide leadership for all quality system activities and proactively assess compliance issues and risks serving as the expert for issue management & issue escalation, with a focus on critical and major quality events. The Senior Manager of Quality Systems will participate in the development of functional strategic plans to support organizational goals and provide guidance to functional areas concerning quality systems.

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

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

Primary Responsibilities Include:

  • Working across GXP functions, lead the ongoing implementation of Dyne’s quality system framework and processes necessary to enable the development and reliable supply of drug product to patients.
  • Develop and/or improve quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, and management review.
  • Track, trend, and analyze quality system data and information including, but not limited to change controls, corrective and preventive actions, audit findings, deviations, complaint information, health authority communications and notifications. Recommend action and continuous improvement plans. Summarize findings and recommendations for management and team awareness and/or present at routine management review meetings.
  • Provide quality system training across the organization.
  • Participate in inspection readiness activities and internal/external audits and inspections.
  • Other duties as assigned to support the growing Quality organization.
  • Promote a quality mindset and quality excellence approach to all activities.

 Education and Skills Requirements:

  • Bachelor’s Degree in a scientific discipline or Quality Systems Management.
  • Minimum of 7 years of related work experience in Quality Assurance within in biotechnology or pharmaceutical environment.
  • Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations.
  • Quality system management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
  • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
  • Experience working with electronic quality systems such as MasterControl / Veeva is strongly preferred.
  • 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.
  • 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.

#LI-Onsite

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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