Senior Director, GMP Quality Operations

Company Overview:

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 X, LinkedIn and Facebook.

Role Summary:

The Senior Director of GMP Quality Operations is responsible for the Quality oversight of external manufacturing operations globally and internal GMP operations for development and commercial programs. This is a critical role within the Quality department responsible for developing and managing contract development manufacturing organization (CDMO) Quality relationships and building the appropriate GMP Quality Operations structure to support Dyne. The Senior Director will also work closely with internal business stakeholders as well as internal Quality functions to deliver quality outcomes. The Senior Director is responsible for oversight of department activities, budgeting, development of personnel and ensuring the quality of deliverables within the role's purview.

Primary Responsibilities Include:

• Ensure organization design, resources, capabilities, and processes are built to support business needs.
• Oversight of external quality operations in support of GMP manufacturing (development and commercial) activities.
• Quality support of Tech Transfer and Process Validation activities.
• Disposition of batches and interfacing with the Qualified Person (QP).
• Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts.
• Oversight of CDMO performance to compliance and Quality Agreement expectations.
• Drive continuous improvement and inspection readiness at CDMOs and internally.
• Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally. Adjudicate on compliance discussions and negotiate any required corrective actions.
• Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence.
• Lead team members, support development of organizational capabilities and talent development.
  
  

Education and Skills Requirements:

• Minimum of a BA/BS degree
• Minimum of 10+ years of experience in a quality role with direct reports, preferably in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company
• Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
• Experience implementing and utilizing various outsourcing and support models
• Experience with disposition of product batches and interfacing with a Qualified Person (QP)
• Excellent written and oral communication skills, including well-developed presentation skills
• Excellent organizational skills and ability to manage multiple priorities
• Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization
• General business management knowledge to assess the impact of project decisions on financial and corporate objectives
• Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities
• Demonstrated flexibility and accountability and ability to identify potential issues and mitigate risks
• Embrace Dyne's core values and culture
• Excitement about the vision and mission of Dyne
  
  

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.