Associate Director, GxP Operations Support Manufacturing Systems

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:

Disclosure Statement:

Flex Designation:

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 Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]