Associate Director, MES & GMP Digital Manufacturing On-Site

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

Benefits offered by this job

Annual bonus

Equity awards

Paid time off

Commuting subsidy

Educational assistance

Job summary

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

You will partner with Manufacturing, Quality, IT, and Engineering to ensure compliant, reliable systems, oversee lifecycle management, data integrity, cybersecurity, and KPI tracking in a fast-paced GMP environment.

Qualifications

• Minimum 8 years of progressive experience in manufacturing, automation, MES implementation, or manufacturing systems engineering within GMP pharmaceutical/biopharmaceutical industries.
• Strong knowledge of GMP, Computer Software Assurance, Data Integrity principles, and 21 CFR Part 11 requirements.
• 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 stakeholders to prioritize and implement business process improvements through digital system capabilities.
• Guide MES strategy and solution design with modular builds, workflow orchestration, and equipment integration.
• Drive standardization to improve reliability, scalability, and supportability.
• Oversee system administration, configuration management, cybersecurity, and backup/recovery planning.
• Establish and monitor KPIs to measure system performance and business value.
• Foster innovation, accountability, collaboration, and continuous improvement within the MES team.
• Provide technical coaching and leadership for project execution and operational excellence.

Skills

MES expertise

Regulatory compliance

Data integrity

Communication & leadership

Automation & PLC/SCADA

Education

Bachelor's in Engineering/Information Systems/Biotechnology

Advanced degree preferred

Tools

POMSnet MES

Job description

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

You will partner with Manufacturing, Quality, IT, and Engineering to ensure compliant, reliable systems, oversee lifecycle management, data integrity, cybersecurity, and KPI tracking in a fast-paced GMP environment.