Associate Director, GxP Operations Support Manufacturing Systems

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

Job Description

General Summary

The Associate Director, GxP Operations Support Manufacturing Systems will provide strategic leadership for the design, delivery, administration, and continuous improvement of the site Manufacturing Execution Systems (MES) and manufacturing control system platforms supporting commercial and clinical operations. This role serves as a key business and technical leader responsible for advancing agile digital manufacturing capabilities.

The Associate Director will partner across Manufacturing, Quality, Validation, Information Technology, and Engineering organizations to ensure compliant, reliable, and scalable manufacturing systems. The role will also support lifecycle management of manufacturing systems including data integrity, industrial networking, historian platform integration, and cybersecurity.

Key Duties and Responsibilities

• Develop and execute the strategic roadmap for MES and manufacturing digitalization initiatives supporting clinical and commercial manufacturing operations.
• Collaborate with Manufacturing, Quality, IT, and Engineering stakeholders to identify, plan, prioritize and implement business process improvements through digital system capabilities.
• Brings deep knowledge of foundational automation engineering concepts to guide MES strategy and solution design including modular builds, workflow orchestration, equipment integration, electronic data capture, analytics, and reporting.
• Drive standardization and best practices to improve reliability, scalability, and supportability.
• Ensure deployment and lifecycle management through system administration, configuration management, cybersecurity assurance, and backup and recovery planning.
• Establish and monitor key performance indicators (KPIs) to measure system performance, adoption, reliability, and business value.
• Foster a culture of innovation, accountability, collaboration, and continuous improvement among MES team members, end users and the network of stakeholders.
• Provide technical coaching and leadership to support team member development, complex project execution, and operational excellence.

Knowledge and Skills

Quality and Compliance

• Support and oversee validation activities, periodic reviews, change controls, deviations, CAPAs, and audit readiness activities.
• Ensure systems remain compliant with applicable regulatory requirements including GMP, GAMP, Data Integrity, and 21 CFR Part 11 standards.
• Facilitate continuous improvement of procedures, documentation, training programs, and support models

Technical Skills

• Expertise in Manufacturing Execution Systems (MES) platforms and electronic batch record solutions, particularly POMSnet MES.
• Knowledge of industrial automation systems including PLCs, HMIs, SCADA, and equipment integration architectures.
• Experience with historian platforms, manufacturing data infrastructure, and analytics solutions.
• Excellent communication, stakeholder management, and organizational leadership skills.
• Ability to balance strategic initiatives with operational support responsibilities in a fast-paced manufacturing environment.

Education and Experience

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

Pay Range

$161,500 - $242,300

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation

On-Site Designated

Flex Eligibility Status

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Poli