Director, QA GMP Operations
Dyne Therapeutics
5 hours ago
On-site
Waltham, MA
$188,000 - $230,000 USD yearly
Operations
Primary Responsibilities:
- Manage external quality operations supporting GMP manufacturing (clinical and commercial) activities.
- Manage deviations, OOS, and OOTs investigations in accordance with cGMP principles and ICH guidelines.
- Review batch records, analytical method reports, and technical reports, including regulatory sections of IND/IMPD and BLA/MAAs.
- Provide QA support for Tech Transfer and Process Validation activities.
- Disposition of GMP batches and interface with the Qualified Person (QP).
- Lead change management to ensure proper evaluation of manufacturing and testing changes by Quality, Regulatory, and Subject Matter Experts.
- Manage CDMO performance to meet Quality Agreement expectations and GMP compliance.
- Drive continuous improvement and inspection readiness.
- Collaborate cross-functionally to complete pre-approval inspection and commercial readiness activities at CDMOs and internally.
- Adjudicate compliance discussions and negotiate required corrective actions.
- Create and foster a culture of collaboration and engagement to advance quality outcomes and operational excellence.
Qualifications & Requirements:
- BA/BS degree.
- 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company.
Required/Preferred Skills:
- Leadership experience managing cross-functional teams; ability to influence priorities and allocate resources without direct authority.
- Experience implementing and using outsourcing/support models.
- Experience with disposition of product batches and interfacing with a Qualified Person (QP).
- Excellent written and oral communication skills, including presentation skills.
- Strong organizational skills and ability to manage multiple priorities.
- Strong collaboration and interpersonal skills with stakeholders at all levels.
- Business management knowledge to assess the impact of project decisions on financial and corporate objectives.
- Ability to drive timelines, meet deadlines, and adapt quickly to changing requirements.
- Embrace core values and culture.
- Manage external quality operations supporting GMP manufacturing (clinical and commercial) activities.
- Manage deviations, OOS, and OOTs investigations in accordance with cGMP principles and ICH guidelines.
- Review batch records, analytical method reports, and technical reports, including regulatory sections of IND/IMPD and BLA/MAAs.
- Provide QA support for Tech Transfer and Process Validation activities.
- Disposition of GMP batches and interface with the Qualified Person (QP).
- Lead change management to ensure proper evaluation of manufacturing and testing changes by Quality, Regulatory, and Subject Matter Experts.
- Manage CDMO performance to meet Quality Agreement expectations and GMP compliance.
- Drive continuous improvement and inspection readiness.
- Collaborate cross-functionally to complete pre-approval inspection and commercial readiness activities at CDMOs and internally.
- Adjudicate compliance discussions and negotiate required corrective actions.
- Create and foster a culture of collaboration and engagement to advance quality outcomes and operational excellence.
Qualifications & Requirements:
- BA/BS degree.
- 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company.
Required/Preferred Skills:
- Leadership experience managing cross-functional teams; ability to influence priorities and allocate resources without direct authority.
- Experience implementing and using outsourcing/support models.
- Experience with disposition of product batches and interfacing with a Qualified Person (QP).
- Excellent written and oral communication skills, including presentation skills.
- Strong organizational skills and ability to manage multiple priorities.
- Strong collaboration and interpersonal skills with stakeholders at all levels.
- Business management knowledge to assess the impact of project decisions on financial and corporate objectives.
- Ability to drive timelines, meet deadlines, and adapt quickly to changing requirements.
- Embrace core values and culture.