Quality Compliance Leader: QMS & Audits

RXinsider LTD.; Greenfield (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

West in Indiana seeks a Quality Compliance Manager to govern the Quality Management System (QMS), ensure regulatory readiness and lead supplier quality governance and risk management. You will head the Quality Systems team reporting to the Site Quality Director, ensuring an inspection-ready program and continual improvement across all quality domains.

The role emphasizes collaboration with regulatory authorities and customers, managing audits, and driving continuous improvement in a fast-paced

Qualifications

• Minimum of 8 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry.
• Experience with EU GMP, 21 CFR Part 210/211, Part 4, ISO13485, 21CFR Part 820 QMSR.
• Experience developing and maintaining a QMS for EU and US markets; hosting audits or inspections.

Responsibilities

• Lead the Quality Systems team through performance management and capability development.
• Own the site QMS and ensure governance, compliance, process ownership, performance monitoring and continual improvement.
• Lead sustained audit readiness and act as the primary Quality Systems representative during customer, corporate, regulatory and Notified Body audits and inspections.
• Provide regulatory compliance leadership, monitor emerging requirements and ensure implementation of required changes, submissions, regulatory commitments and manufacturing authorization requirements.
• Act as the primary liaison with customers, regulatory authorities, the Qualified Person, Corporate Quality and other West sites on Quality Systems and compliance matters.

Skills

Quality leadership

Regulatory knowledge

Audit readiness

Quality systems

Education

Bachelor’s degree in technical discipline

Tools

MS Office

ERP systems

Statistical software

Job description

West in Indiana seeks a Quality Compliance Manager to govern the Quality Management System (QMS), ensure regulatory readiness and lead supplier quality governance and risk management. You will head the Quality Systems team reporting to the Site Quality Director, ensuring an inspection-ready program and continual improvement across all quality domains.

The role emphasizes collaboration with regulatory authorities and customers, managing audits, and driving continuous improvement in a fast-paced