Associate Director, GxP Operations Support Manufacturing Systems
Vertex Pharmaceuticals · Boston, MA
QualityFull-time$162k–$242kCompany career page
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Role summary
Associate Director leading strategic design and continuous improvement of Manufacturing Execution Systems and control platforms for clinical and commercial pharmaceutical operations. Serves as key technical and business leader partnering across manufacturing, quality, IT, and engineering to advance digital manufacturing capabilities and ensure regulatory compliance.
What they're looking for
- Bachelor's degree in Engineering, Information Systems, Biotechnology, or related technical discipline
- Minimum 8 years progressive experience in manufacturing, MES implementation, or manufacturing systems engineering in GMP pharmaceutical/biopharmaceutical industry
- Expertise in Manufacturing Execution Systems platforms and electronic batch record solutions, particularly POMSnet MES
- Strong knowledge of GMP regulations, Computer Software Assurance, Data Integrity, and 21 CFR Part 11 requirements
- Experience with industrial automation systems including PLCs, HMIs, SCADA, and equipment integration architectures
- Proven track record leading cross-functional initiatives and delivering business-critical system implementations
- Excellent communication, stakeholder management, and organizational leadership skills
What you'll be doing
- Develop and execute strategic roadmap for MES and manufacturing digitalization initiatives for clinical and commercial operations
- Collaborate with Manufacturing, Quality, IT, and Engineering stakeholders to identify and implement business process improvements through digital capabilities
- Ensure system deployment and lifecycle management including validation, change controls, data integrity, and cybersecurity assurance
- Establish and monitor KPIs to measure system performance, adoption, reliability, and business value
- Provide technical coaching and leadership to support team development, project execution, and operational excellence
Privacy & handoff
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