Hiring: Quality Systems Manager Company: West Pharmaceutical Services Location: Greenfield, IN Job Posted Time: 2026-09-16 21:02:02 Employment Type: On-site Target Skills & Keywords : Microsoft Office, Regulatory Compliance, Risk Management, Stakeholder Management About the job Experience: •Minimum of 8 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry. •Proven experience in Medical Device and Pharmaceutical Packaging and Combination Products regulations e.g., EU GMP, 21 CFR Part 210/211 and Part 4, ISO13485, 21CFR Part 820 QMSR. •Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven. •Excellent computer skills, experience with MS Office, ERP systems, Statistical software etc. •Demonstrated experience leading people, Quality Systems, compliance programs or cross-functional quality improvement initiative. Required Skills: •This is an onsite position requiring the team member to be onsite 5 days a week. •No relocation is provided for this opportunity. •There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. •We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. •Lead, develop and coach the Quality Systems team through effective performance management, succession planning and capability development. •Own the site QMS, ensuring effective governance, compliance, process ownership, performance monitoring and continual improvement. •Oversee deviations and non-conformances, CAPA, change control, complaints, document control, training, Management Review, Product Quality Review, supplier quality, validation governance and quality risk management. •Develop and implement the site Quality Systems strategy and roadmap, aligned with regulatory, customer and West requirements. Qualifications: •Bachelor’s Degree in a technical discipline to include; Science, Quality or Engineering or equivalent experience •Solid functional working knowledge of applicable EU GMP requirements, ISO 13485, ISO 14971 and US 21 CFR Parts 210, 211, 820 QMSR and Part 4. •Lead auditor qualification or equivalent audit experience; supplier audit experience is desirable. •Strong leadership, coaching, stakeholder management, analytical, organizational and communication skills. •Demonstrated capacity to prepare clear, concise and audit-ready documentation, analyze trends and drive sustainable corrective and preventive action. •Lean Sigma training, ideally Green Belt level, with experience leading improvement programs. •Thrive in a fast-paced environment where teamwork and collaboration drive success. •Bring a positive, can-do attitude every day as we build and grow together. •Contribute to ramping up a state-of-the-art manufacturing facility from the ground up. •Embrace change and innovation as we launch new operations at record speed. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!