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 - $242,300Disclosure 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 DesignatedFlex 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]
Skills Required
- 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 GMP pharmaceutical or biopharmaceutical industry
- Experience 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
- Expertise with Manufacturing Execution Systems and electronic batch record solutions, particularly POMSnet MES
- Knowledge of industrial automation systems, including PLCs, HMIs, SCADA, and equipment integration architectures
- Knowledge of historian platforms, manufacturing data infrastructure, and analytics solutions
- Advanced degree
Vertex Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.
-
Parental & Family Support — Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
-
Leave & Time Off Breadth — Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
-
Retirement Support — Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.
Vertex Pharmaceuticals Insights
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
