Senior Quality Leader - Laboratory & Compliance

West Pharmaceutical Services, Inc; Greenfield (IN); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

No relocation

Community Involvement

Continuous Learning & Development

Global Career Opportunities

Inclusive & Collaborative Culture

Recognition & Rewards

Job summary

West Pharmaceutical Services, Inc. is seeking a Senior Quality Specialist (Laboratory) to lead quality systems oversight and support laboratory operations in Greenfield, IN.

The role drives continual improvement, regulatory compliance, and timely closure of quality issues across multiple teams. Key duties include overseeing CAPAs, deviations, change control, document control, and investigations, while maintaining audit readiness and data integrity.

Qualifications

• 5+ years experience in Quality Assurance or regulated environments.
• Bachelor's degree preferred; equivalent work experience considered.
• Experience with CAPA, deviations, change control, document control, investigations.
• Knowledge of regulatory audits and inspection readiness.
• Ability to communicate effectively with cross-functional teams.

Responsibilities

• Oversee QMS processes and ensure compliance with ISO, GMP, and regulatory requirements.
• Lead investigations with root cause analysis and corrective actions.
• Provide QA oversight for CAPA, deviations, change control, and document control.
• Prepare metrics and reports to support decision-making.
• Coordinate internal/external audits and regulatory inspections.

Skills

Quality Assurance

GMP knowledge

ISO knowledge

Audit readiness

Education

High School diploma or equivalent

Bachelor's degree in Engineering, Science, Quality or related field

Tools

LIMS

SAP

MasterControl

SharePoint

Job description

West Pharmaceutical Services, Inc. is seeking a Senior Quality Specialist (Laboratory) to lead quality systems oversight and support laboratory operations in Greenfield, IN.

The role drives continual improvement, regulatory compliance, and timely closure of quality issues across multiple teams. Key duties include overseeing CAPAs, deviations, change control, document control, and investigations, while maintaining audit readiness and data integrity.