Role Summary:

The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance. The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview.

This is an onsite role based in Waltham, MA.

Primary Responsibilities Include:

• Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities.
• Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines.
• Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs.
• QA support of Tech Transfer and Process Validation activities.
• Disposition of GMP 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.
• Manage CDMO performance within Quality Agreement expectations and GMP compliance.
• Drive continuous improvement and inspection readiness.
• 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.

Education and Skills Requirements:

• Minimum of a BA/BS degree
• Minimum of 10+ years of experience 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
• Embrace Dyne’s core values and culture

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