Quality Systems Lead — Onsite Compliance & Audits

West Pharmaceutical Services; Greenfield (IA); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

West Pharmaceutical Services, Inc is seeking a Quality Compliance Manager to lead the QMS governance, regulatory readiness and continuous improvement for the site. You will drive audits, CAPA, change control and risk management while aligning with global requirements.

The role requires 8+ years in quality/regulatory management, strong leadership and collaboration with customers and regulators. Onsite work five days a week in the US; relocation not provided.

Formación

• 8+ years of Quality/Regulatory management in process-based manufacturing for medical devices/pharma.
• Experience with EU GMP, 21 CFR Part 210/211, Part 4, ISO13485, 21 CFR Part 820 QMSR.
• Experience hosting customer, corporate and regulatory audits/inspections.
• Proven leadership of Quality Systems, compliance programs and cross-functional teams.
• Strong analytical skills, data-driven decision making and problem solving.
• Lean Sigma training (Green Belt preferred) and improvement program leadership.

Responsabilidades

• Lead the Quality Systems team and site QMS governance and compliance.
• Drive audit readiness and act as primary QA liaison during audits.
• Develop and implement regulatory changes and CAPA programs.
• Manage validation governance, deviations, CAPA and change control.
• Establish KPIs, monitor trends and report QMS performance.
• Collaborate with customers, regulators and other sites on quality matters.
• Support new product introductions and technology transfers.
• Ensure training and document control adherence.

Conocimientos

Quality management

Regulatory compliance

Leadership

Auditing

Risk management

Educación

Bachelor’s degree in Science/Engineering or equivalent

Herramientas

MS Office

ERP systems

Statistical software

Descripción del empleo

West Pharmaceutical Services, Inc is seeking a Quality Compliance Manager to lead the QMS governance, regulatory readiness and continuous improvement for the site. You will drive audits, CAPA, change control and risk management while aligning with global requirements.

The role requires 8+ years in quality/regulatory management, strong leadership and collaboration with customers and regulators. Onsite work five days a week in the US; relocation not provided.