Global QA & GMP Operations Director

Executive Recruit; Cambridge (MA); Presencial; USD 180.000 - 230.000; Jornada completa

Descripción de la vacante

Executive Recruit is assisting a clinical-stage biotech company in recruiting a Director of QA GMP Operations. The role oversees GMP quality across external manufacturing partners and internal GMP programs, ensuring compliance and quality deliverables for development and commercial programs.

The Director will collaborate with internal QA and business stakeholders to drive QA activities, manage deviations and batch disposition, and lead continuous improvement to support regulatory readiness and

Formación

• 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 and influencing without direct authority.
• Experience with outsourcing models and CDMOs.
• Experience with disposition of product batches and interfacing with a Qualified Person (QP).
• Strong communication and presentation skills.
• Excellent organizational and multi-priority management.
• Collaboration with internal and external stakeholders at all levels.
• Understanding of financial and corporate objective impact.

Responsabilidades

• Oversee external quality operations for GMP manufacturing (clinical and commercial).
• Lead deviations, OOS, OOT investigations following cGMP and ICH guidelines.
• Review batch records, analytical method reports, and 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 SMEs.
• 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.

Conocimientos

GMP Quality Ops

Leadership

Cross-functional Leadership

Regulatory Liaison

Outsourcing Models

Batch Release

Quality Systems

Process Improvement

Vendor/CDMO Oversight

Change Management

Educación

Bachelor's degree

Descripción del empleo

Executive Recruit is assisting a clinical-stage biotech company in recruiting a Director of QA GMP Operations. The role oversees GMP quality across external manufacturing partners and internal GMP programs, ensuring compliance and quality deliverables for development and commercial programs.

The Director will collaborate with internal QA and business stakeholders to drive QA activities, manage deviations and batch disposition, and lead continuous improvement to support regulatory readiness and