Senior Quality Systems Lead — Compliance & Improvement

RXinsider LTD.; Greenfield (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

West Pharmaceutical Services is seeking a Senior Quality Systems Specialist to oversee quality management activities, drive continuous improvement, and ensure site compliance with regulatory and customer standards. You will liaise with cross-functional teams to maintain data integrity and accountability in quality processes.

You will also coordinate audits, CAPA governance, change management, and risk assessment while mentoring staff to uphold a culture of quality and compliance across the site.

Qualifications

• Minimum of 5 years’ experience in a high-volume manufacturing environment, ideally pharma.
• Working knowledge of ISO 13485 / 21 CFR Part 820 QMSR / 21 CFR Part 210/211.

Responsibilities

• Harmonize and deploy site quality systems into standardized processes.
• Provide training on QMS processes: CAPA, Deviation, Document Control, Change Management.
• Lead investigations, root cause analysis, containment and corrective actions.
• Monitor quality metrics and escalate systemic risks to leadership.
• Support regulatory submissions and audit readiness activities.

Education

Bachelor's Degree in Engineering, Quality, Science or equivalent experience

Job description

West Pharmaceutical Services is seeking a Senior Quality Systems Specialist to oversee quality management activities, drive continuous improvement, and ensure site compliance with regulatory and customer standards. You will liaise with cross-functional teams to maintain data integrity and accountability in quality processes.

You will also coordinate audits, CAPA governance, change management, and risk assessment while mentoring staff to uphold a culture of quality and compliance across the site.