Associate Director, MES & GxP Ops – Digital Manufacturing

Vertex Pharmaceuticals; Boston (MA); On-site; USD 162,000 - 242,000; Full time

Benefits offered by this job

Total Rewards benefits

Commuting subsidy

Education assistance

Charitable matching

401(k) plan

Company shutdown holidays

Job summary

Vertex Pharmaceuticals is seeking an Associate Director, GxP Operations Support Manufacturing Systems to lead the strategy, design, and ongoing improvement of MES and manufacturing control systems across clinical and commercial operations.

You will partner with Manufacturing, Quality, IT, and Engineering to ensure compliant, reliable systems, driving lifecycle management, data integrity, and cybersecurity while delivering value and continuous improvement in a fast-paced biopharma environment.

Qualifications

• Bachelor's degree in Engineering, Information Systems, Biotechnology or related technical discipline.
• Minimum 8 years of progressive experience in manufacturing, automation, MES implementation, or manufacturing systems engineering within GMP pharma/biopharma.
• Strong knowledge of GMP, Computer Software Assurance, Data Integrity, and 21 CFR Part 11.
• Proven track record leading cross-functional initiatives and delivering business-critical system implementations.

Responsibilities

• Develop and execute the strategic roadmap for MES and manufacturing digitalization initiatives.
• Collaborate with cross-functional stakeholders to implement business process improvements through digital system capabilities.
• Provide technical coaching and leadership to support team development and project execution.
• Drive standardization to improve reliability, scalability, and supportability of systems.
• Establish lifecycle management, cybersecurity, backup/recovery planning, and KPI monitoring.

Skills

Communication

Leadership

Stakeholder management

Regulatory compliance knowledge

Education

Bachelor's degree in Engineering or Information Systems or Biotechnology

Advanced degree preferred

Tools

POMSnet MES

Job description

Vertex Pharmaceuticals is seeking an Associate Director, GxP Operations Support Manufacturing Systems to lead the strategy, design, and ongoing improvement of MES and manufacturing control systems across clinical and commercial operations.

You will partner with Manufacturing, Quality, IT, and Engineering to ensure compliant, reliable systems, driving lifecycle management, data integrity, and cybersecurity while delivering value and continuous improvement in a fast-paced biopharma environment.