Vice President, Head of Global Quality

Role Summary:

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.

Primary Responsibilities Include:

• Provide leadership, vision, and direction to the Global Quality Assurance Organization to ensure the highest standards are met across the organization to achieve Dyne’s objectives
• Responsible for the oversight of the Global Quality Management System, Quality Risk Management (QRM), Annual Product Review, Global Document Management, Global Quality Issue Management (GIM), Product Complaints, Product Recall, Data Integrity Quality Oversight, and Supplier Quality Management
• Lead team to maintain and improve upon a risk-based and fit-for-purpose global QMS ensuring it is effectively and efficiently managed and continuously improved to sustain compliance with current and evolving global health authority requirements and regulations
• Continually evaluate and improve quality systems, initiatives, priorities, and timelines
• Ensure phase appropriate compliance with quality systems, quality procedures, and quality policies
• Work closely with all functions and partners across the organization including manufacturing, supply chain, Regulatory Affairs, Preclinical, and Clinical Operations to ensure overall global quality and compliance
• Ensure that the Global Quality Systems meet regulatory standards required by FDA, EMA, and other global regulatory authorities
• Drive, introduce, and promote quality culture and continuous improvement that will focus on delivering Quality through Dyne Core Values
• Build upon the quality governance to meet business and compliance needs
• Ensure overall global Quality and Compliance oversight for manufacturing, supply chain, nonclinical and clinical
• Establish strong working relationships with external manufacturers of our products and ensure alignment of our quality systems and requirements with these CMOs
• Responsible for Global Inspection Readiness of Dyne and our partners and vendors
• Oversee all GXP compliance audits as required
• Ensure quality oversight as it pertains to electronic systems used to support GXP related activities
• Oversee validation of electronic systems used for GXP or regulatory submissions
• Provide leadership in global issue management (GIM) including product complaints and product recall process management and reporting
• Communicate quality risks that may impact our regulatory compliance in a timely manner to Executive Management

Education and Skills Requirements:

• 15+ years of relevant experience in GXP, QA management or QA leadership in a biopharmaceutical/pharmaceutical company
• Degree in biology, biochemistry, chemistry, or related field preferred
• Experience in leading the Quality function for a biopharmaceutical company and deep knowledge of GxPs
• Proven experience in QA processes and systems to support biopharmaceutical development and launch
• Extensive knowledge and in-depth experience of implementation of Global Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities
• Knowledge of ICHQ9 principles with demonstrated ability to utilize Quality Risk Management principles in everyday practice
• Strong collaborative, influencing, and interpersonal skills with the ability to perform effectively across all levels
• Excellent verbal, written, and presentation skills
• Experience with implementing and managing QA documentation systems
• Demonstrates strong organizational skills, including the ability to prioritize workload
• Ability to work well in a deadline-driven environment and capable of supporting multiple programs
• Strong leadership presence with the ability to influence across the organization

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