Senior Manager, GMP Inspection Readiness
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Operations
Senior Manager, GMP Inspection Readiness
Role Responsibilities
- Drive real-time GMP inspection readiness across Vertex’s CMO network (small molecule, biologics, cell & gene therapies, medical devices).
- Develop, implement, and continuously enhance inspection readiness plans aligned with regulatory filings, site activities, and business needs.
- Mature the inspection readiness program by strengthening tools, processes, governance, and execution standards.
- Use project management tools to ensure readiness activities are tracked, progressed efficiently, and delivered on time.
- Create/manage project plans, timelines, metrics, and dashboards for CMO readiness status.
- Prepare inspection materials (evidence binders, opening presentations, SME lists, inspection storyboards).
- Support regulatory inspections from preparation through follow-up (readiness coordination, logistics/onsite sponsor support as required, observation response support incl. CAPA tracking).
- Maintain inspection-related history/documentation for trending and organizational learning.
- Identify and mitigate inspection risks; perform routine Quality System checks.
- Partner with CMOs and cross-functional teams to align on expectations/deliverables and monitor readiness pre-/post-approval.
- Author/revise SOPs and controlled documents; support internal GMP inspections and additional compliance/CME initiatives as needed.
Qualifications
- Master’s + 3–4 years relevant experience, or Bachelor’s (scientific/allied health) + 5+ years, or comparable background.
- Strong project management, analytical/problem-solving, stakeholder management, and communication (written/verbal/presentation/facilitation).
- Broad GxP knowledge; strong GMP regulatory knowledge and application.
- Practical experience with quality risk management, RCA, CAPA development/tracking, quality systems, and audit/inspection processes.
- Experience supporting regulatory inspections/inspection readiness and inspection observation follow-up.
- Ability to interpret/apply GMP, ICH, USP, and relevant guidance.
Preferred Qualifications
- Operational Quality Assurance experience in analytical/manufacturing/CMO environments.
- Pre-/post-approval inspection readiness and compliance monitoring across CMO networks.
- Modality experience (small molecule, biologics, cell & gene therapies, medical devices).
- Global, multi-site/complex supply network experience.
Role Responsibilities
- Drive real-time GMP inspection readiness across Vertex’s CMO network (small molecule, biologics, cell & gene therapies, medical devices).
- Develop, implement, and continuously enhance inspection readiness plans aligned with regulatory filings, site activities, and business needs.
- Mature the inspection readiness program by strengthening tools, processes, governance, and execution standards.
- Use project management tools to ensure readiness activities are tracked, progressed efficiently, and delivered on time.
- Create/manage project plans, timelines, metrics, and dashboards for CMO readiness status.
- Prepare inspection materials (evidence binders, opening presentations, SME lists, inspection storyboards).
- Support regulatory inspections from preparation through follow-up (readiness coordination, logistics/onsite sponsor support as required, observation response support incl. CAPA tracking).
- Maintain inspection-related history/documentation for trending and organizational learning.
- Identify and mitigate inspection risks; perform routine Quality System checks.
- Partner with CMOs and cross-functional teams to align on expectations/deliverables and monitor readiness pre-/post-approval.
- Author/revise SOPs and controlled documents; support internal GMP inspections and additional compliance/CME initiatives as needed.
Qualifications
- Master’s + 3–4 years relevant experience, or Bachelor’s (scientific/allied health) + 5+ years, or comparable background.
- Strong project management, analytical/problem-solving, stakeholder management, and communication (written/verbal/presentation/facilitation).
- Broad GxP knowledge; strong GMP regulatory knowledge and application.
- Practical experience with quality risk management, RCA, CAPA development/tracking, quality systems, and audit/inspection processes.
- Experience supporting regulatory inspections/inspection readiness and inspection observation follow-up.
- Ability to interpret/apply GMP, ICH, USP, and relevant guidance.
Preferred Qualifications
- Operational Quality Assurance experience in analytical/manufacturing/CMO environments.
- Pre-/post-approval inspection readiness and compliance monitoring across CMO networks.
- Modality experience (small molecule, biologics, cell & gene therapies, medical devices).
- Global, multi-site/complex supply network experience.