Quality Systems Leader – Onsite, Regulatory Ready

West Pharmaceutical Services, Inc; Greenfield (IN); On-site; USD 110,000 - 170,000; Full time

Job summary

West Pharmaceutical Services, Inc. in Greenfield, IN is seeking a Quality Systems Manager to lead the governance and continual improvement of the Quality Management System. The role ensures QMS effectiveness, inspection readiness and compliance with drug, device and customer requirements.

You will overseeCAPA, change control, training and supplier quality governance. The person will drive QMS strategy, regulatory readiness and risk management, reporting to the Site Quality Director and

Qualifications

• Bachelor’s degree in a technical field with quality or engineering focus.
• Minimum 8 years in quality/regulatory management in process-based manufacturing.
• Experience hosting audits and regulating compliance in medical/pharma domains.

Responsibilities

• Lead the Quality Systems team and governance of the QMS.
• Ensure inspection readiness and regulatory compliance for US/EU markets.
• Oversee deviations, CAPA, change control, training and management reviews.
• Develop site quality strategy and drive continuous improvement initiatives.
• Represent Quality during audits and liaise with customers and authorities.

Skills

Quality management

Regulatory knowledge

Leadership

Auditing

Continuous improvement

Risk management

Data analysis

Communication

Education

Bachelor's degree in a technical discipline (Science, Quality or Engineering)

Tools

MS Office

ERP systems

Statistical software

Job description

West Pharmaceutical Services, Inc. in Greenfield, IN is seeking a Quality Systems Manager to lead the governance and continual improvement of the Quality Management System. The role ensures QMS effectiveness, inspection readiness and compliance with drug, device and customer requirements.

You will overseeCAPA, change control, training and supplier quality governance. The person will drive QMS strategy, regulatory readiness and risk management, reporting to the Site Quality Director and