Onsite Quality Systems Leader - Compliance & Improvement

West Pharmaceutical Services, Inc; Greenfield (IN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Job summary

West Pharmaceutical Services, Inc. in Greenfield, Indiana, seeks a Quality Compliance Manager to lead governance, compliance and continual improvement of the QMS. The role ensures inspection readiness and alignment with EU/US requirements, customer and corporate standards.

The Quality Systems team reports to the Site Quality Director. You will drive audit readiness, risk assessment, supplier quality governance and regulatory submissions, while championing a patient-first, right-first-time

Qualifications

• 8+ years of Quality/Regulatory management in process-based manufacturing.
• Experience with EU GMP, 21 CFR Part 210/211/4, ISO13485, 21 CFR Part 820 QMSR.
• Experience hosting audits/inspections for EU and US markets.

Responsibilities

• Lead Quality Systems governance and continual improvement activities.
• Ensure QMS compliance, audit readiness and regulatory alignment.
• Oversee deviations, CAPA, change control and document control.
• Drive risk management, supplier quality governance and training.
• Collaborate with customers, regulatory authorities and other West sites.

Skills

Quality leadership

Regulatory management

Audit readiness

CAPA management

Risk management

Continuous improvement

Data analysis

Cross-functional collab

Education

Bachelor’s Degree in Science/Quality/Engineering

Tools

MS Office

ERP systems

Statistical software

Job description

West Pharmaceutical Services, Inc. in Greenfield, Indiana, seeks a Quality Compliance Manager to lead governance, compliance and continual improvement of the QMS. The role ensures inspection readiness and alignment with EU/US requirements, customer and corporate standards.

The Quality Systems team reports to the Site Quality Director. You will drive audit readiness, risk assessment, supplier quality governance and regulatory submissions, while championing a patient-first, right-first-time