Dyne Therapeutics is a clinical-stage muscle disease company focused on 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. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
The Head of Global Quality is responsible for the overall strategy and operational management of Dyne’s Quality Assurance program. This role is accountable for the execution of the GXP Quality Systems to support Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). In accordance with FDA, ICH, EMA, and other global regulations, the Head of Global Quality will provide leadership and guidance to the organization on global quality matters. This role plays will be integral in continuing to foster a culture of quality, through the effective management of the Quality Management System (QMS). The Head of Global Quality will ensure that the QMS is effectively managed and continuously improved to sustain compliance with Health Authority regulations.
This position requires a broad range of knowledge and experience with quality assurance, quality systems, and regulatory compliance, understanding the international regulatory landscape for the manufacturing, packaging, and distribution of Dyne’s portfolio.
This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.
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.