Onsite Quality Systems Leader - Audit & Compliance

West Pharmaceutical Services; Greenfield (IN); On-site; USD 120,000 - 170,000; Full time

Job summary

West Pharmaceutical Services in Indiana is seeking a Quality Systems Manager to lead governance, compliance and continual improvement of the Quality Management System (QMS) for West, Indiana. The role ensures the QMS remains inspection-ready and compliant with applicable drug product, medical device, and customer requirements.

The position leads the Quality Systems team and is responsible for regulatory readiness, supplier quality governance, risk management and continuous improvement; it

Qualifications

• Bachelor’s degree in science, quality or engineering or equivalent.
• 8+ years of quality/regulatory management in medical device/pharma manufacturing.
• Experience with EU GMP, 21 CFR Part 210/211 and Part 4, ISO13485, 21 CFR 820 QMSR.
• Experience hosting audits/inspections from customers, regulatory authorities.
• Strong leadership and quality management experience with data analysis and deadlines.
• Proficient with MS Office and ERP systems; statistical software is a plus.

Responsibilities

• Lead the Quality Systems team through performance management and development.
• Own the site QMS governance, compliance and continual improvement.
• Oversee deviations, CAPA, change control, complaints, document control.
• Lead audit readiness and represent Quality Systems during audits.
• Provide regulatory leadership and manage regulatory commitments.
• Liaise with customers, regulators and other West sites on quality matters.
• Monitor QMS performance through KPIs and risk management.

Skills

Leadership

Quality management

Regulatory compliance

Data analysis

Communication

ERP systems

MS Office

Education

Bachelor's degree in science/quality/engineering

Tools

MS Office

ERP systems

Statistical software

Job description

West Pharmaceutical Services in Indiana is seeking a Quality Systems Manager to lead governance, compliance and continual improvement of the Quality Management System (QMS) for West, Indiana. The role ensures the QMS remains inspection-ready and compliant with applicable drug product, medical device, and customer requirements.

The position leads the Quality Systems team and is responsible for regulatory readiness, supplier quality governance, risk management and continuous improvement; it