Senior Director, Quality Management System

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 polices, 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 partnership 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:

• Minimum of a BA/BS degree
• Minimum of 10+ years of experience in a quality role with direct reports, preferably implementing and overseeing GXP QMS for 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 implementation of electronic quality management systems, Veeva experience preferred
• Experience with validation of GxP computerized systems
• 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

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