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 Twitter, LinkedIn and Facebook.
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:
Education and Skills Requirements:
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.