Senior Manager, GMP Inspection Readiness (Biotech)

TL;DR

Senior Manager, GMP Inspection Readiness (Biotech): Leading real-time inspection readiness activities across a global CMO network for diverse modalities including small molecules, biologics, and cell/gene therapies. Focus on developing readiness plans, managing cross-functional project execution, and ensuring continuous compliance with global GMP regulations.

Location: Must be based in the United States (Hybrid-eligible role based in Boston, MA).

Company

Vertex is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Drive real-time GMP inspection readiness across the CMO network for multiple product modalities.
• Develop and implement comprehensive inspection readiness plans, including evidence binders and SME lists.
• Manage project timelines, metrics, and dashboards to monitor CMO readiness status and mitigate risks.
• Support regulatory inspections from preparation through follow-up, including CAPA tracking and observation responses.
• Partner with internal and external stakeholders to ensure ongoing compliance and continuous quality improvement.
• Author and maintain SOPs and controlled documents to support CMC compliance.

Requirements

• Master’s degree with 3–4 years or Bachelor’s degree with 5+ years of relevant experience in a scientific or allied health field.
• Strong working knowledge of GMP regulations and GxP requirements across product lifecycles.
• Proven experience supporting regulatory inspections and inspection readiness activities.
• Demonstrated project management skills with the ability to lead complex, cross-functional initiatives.
• Ability to work in a fast-paced, dynamic environment with a focus on urgency and strategic problem-solving.
• Excellent written and verbal communication skills for stakeholder management and presentation.

Nice to have

• Experience in Operational Quality Assurance within an analytical or manufacturing environment.
• Background in global, multi-site, or complex supply network environments.
• Specific experience with small molecules, biologics, or cell and gene therapies.

Culture & Benefits

• Inclusive market-leading benefits including medical, dental, and vision coverage.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance programs and student loan repayment support.
• 401(k) retirement plan with company matching.
• Flexible work environment with hybrid options.