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. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients. 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 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 ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.