Director, QA GMP Operations

Primary Responsibilities

• 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