MES & GxP Digital Manufacturing Leader

Biopharma Careers; Boston (MA); On-site; USD 162,000 - 242,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k)

Paid time off

Educational assistance

Student loan repayment

Commuting subsidy

Charitable matching

Company-wide shutdown

Job summary

Vertex is seeking an Associate Director, GxP Operations Support Manufacturing Systems to lead the design, delivery, and lifecycle management of MES and manufacturing control platforms for clinical and commercial operations.

You will partner across Manufacturing, Quality, IT, Validation, and Engineering to ensure compliant, scalable systems, advancing agile digital manufacturing capabilities and data integrity.

Qualifications

• Minimum 8 years of progressive experience in manufacturing, automation, MES implementations, or manufacturing systems engineering in GMP/pharma.
• Strong knowledge of GMP, Computer Software Assurance, Data Integrity, and 21 CFR Part 11.
• Proven track record leading cross-functional initiatives and delivering critical system implementations.

Responsibilities

• Develop and execute the strategic roadmap for MES and digitalization supporting clinical and commercial operations.
• Collaborate with Manufacturing, Quality, IT, and Engineering to plan and implement process improvements through digital systems.
• Guide MES strategy and solution design, including modular builds, workflow orchestration, and data capture.

Skills

MES expertise

Industrial automation

Data/instrumentation analytics

Communication & leadership

Strategy vs. operations balance

Education

Bachelor's degree in Engineering/Info Systems/Biotech

Advanced degree preferred

Tools

POMSnet MES

Job description

Vertex is seeking an Associate Director, GxP Operations Support Manufacturing Systems to lead the design, delivery, and lifecycle management of MES and manufacturing control platforms for clinical and commercial operations.

You will partner across Manufacturing, Quality, IT, Validation, and Engineering to ensure compliant, scalable systems, advancing agile digital manufacturing capabilities and data integrity.