Hiring: Senior Quality Systems Specialist Company: West Pharmaceutical Services Location: Greenfield, IN Job Posted Time: 2026-09-16 21:02:07 Employment Type: On-site Target Skills & Keywords : Change Management, Risk Management, Root Cause Analysis About the job Experience: •Minimum of 5 years’ experience of working in a high-volume manufacturing environment ideally in the pharmaceutical industry. •Solid functional working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 QMSR/21 CFR Part 210/211 is essential. 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. •Actively facilitate and support harmonization and deployment of site quality systems into standardized Operating Unit-level processes, ensuring effective implementation, consistency, and the sharing of best practices across the network. •Provide training and guidance on Quality Management System (QMS) processes, including Change Management, CAPA, Deviation Management, Document Control, and associated compliance requirements. •Manage key quality system processes at site level, including Global Alerts, Document Control System sub-administration, CAPA governance, and Change Management oversight. •Lead and support investigations related to Quality System issues, ensuring robust root cause analysis and the implementation of effective containment, corrective, and preventive actions. Qualifications: •Bachelor's Degree in Engineering, Quality, Science or equivalent experience required •Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description •Able to comply with the company’s safety policy at all times. •Able to comply with the company’s quality policy at all times. •Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 QMSR, 21 CFR Part 4, 21 CFR Part 210/211, EU GMP Volume 4 is preferred. •A background in drug handling would be considered an advantage. •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!