What are the responsibilities and job description for the Senior Director, Quality Management System position at Dyne Tx?
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Senior Director, Quality Management System
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).
Role Summary :
The Senior Director, Quality Management System (QMS) role is accountable for developing and implementing Dyne’s QMS framework encompassing Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Pharmacovigilance Practices (GVP). This role will also be responsible for electronic systems that support the QMS and partnering across our QA team in the support of connected and integrated solutions for our QA specific processes.
This role is expected to apply subject matter expertise to lead and identify opportunities, shape objectives and drive execution of key functional and corporate objectives. This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities Include :
- Develop and implement a fit-for-purpose, risk-based GXP Quality Management System framework that covers GMP, GCP, GLP, and GVP.
- Develop programs / processes to drive a risk-based and outcomes-focused Quality Management System, supporting compatibility and integration of Dyne’s core values and quality process-driven core principles.
- Lead the development of Quality Governance (e.g. Management Review, Quality Council, etc.) and related processes (e.g. quality policies, manuals, SOPs, etc.) and documentation, including metrics, dashboards, readouts in support of Quality Oversight.
- Manage the internal and external audit program and provide quality oversight for internal GXP systems and software.
- Serve as the business owner for Quality process-level controlled documents and learning and training programs including the ownership of technologies and vendors that support these areas as well as defining measurable outcomes to indicate that the processes are delivering as needed.
- Lead quality professionals responsible for managing processes related to documentation and training, and providing high levels of support for the enterprise as it relates to achieving documentation and training deliverables.
- Influence and guide in a collaborative fashion, across all aspects of the quality organization partnering with peers to enable quality processes within their space as well as establishing supportive partnerships across the organization.
- Maintain up-to-date knowledge of guidance, regulations, and industry standards for Quality and compliance.
- Manage contracts and budgets as needed.
Education and Skills Requirements :
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