Senior Quality Systems & Compliance Lead

West Pharmaceutical Services; Greenfield (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

West Pharmaceutical Services in Indiana seeks a Senior Quality Systems Specialist to oversee site quality systems, ensure regulatory compliance, and drive continuous improvement. You will coordinate CAPA, change management, document control, and investigations while liaising with cross-functional teams to meet customer specifications.

The role emphasizes risk monitoring, data-driven decision making, and support for regulatory bodies and inspections within a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in engineering, quality, science or equivalent experience.
• Minimum 5 years’ experience in a high-volume manufacturing environment (pharma preferred).
• Working knowledge of ISO 13485 / 21 CFR Part 820 QMSR / 21 CFR Part 210/211 is essential.

Responsibilities

• Coordinate site quality systems within standardized operating unit processes.
• Provide training on QMS processes including CAPA, Change Management, Document Control.
• Lead investigations with robust root-cause analysis and CAPA implementation.
• Monitor quality risks, trends, and compliance to senior leadership.
• Support regulatory submissions and inspection readiness activities.
• Drive continuous improvement of procedures and systems in line with regs.

Skills

Quality systems

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Auditing

Education

Bachelor's degree in engineering/quality/science

Tools

QMS software

Job description

West Pharmaceutical Services in Indiana seeks a Senior Quality Systems Specialist to oversee site quality systems, ensure regulatory compliance, and drive continuous improvement. You will coordinate CAPA, change management, document control, and investigations while liaising with cross-functional teams to meet customer specifications.

The role emphasizes risk monitoring, data-driven decision making, and support for regulatory bodies and inspections within a fast-paced manufacturing environment.