Associate Director, GxP Operations Support Manufacturing Systems

Vertex Inc.•Boston, MA

3d•$161,500 - $242,300•Onsite

About The Position

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.

Requirements

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
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.
Bachelor’s degree in Engineering, Information Systems, Biotechnology, or a related technical discipline.
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.

Nice To Haves

Advanced degree preferred.

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.