Global Change Control Leader, Quality Systems

Perrigo; Allegan Township (MI); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Perrigo in Allegan, MI is hiring a Corporate Quality Systems Change Control Specialist to drive the global quality change-management program. You will coordinate governance meetings, develop SOPs, and partner with Quality, Regulatory Affairs, Operations, IT, and other functions to ensure compliant change lifecycle execution.

The role emphasizes data-driven decision making, QMS process optimization, and applicable GMP standards across global sites. Travel up to 10% may be required.

Qualifikationen

• Bachelor's degree in a scientific, engineering, data science, or related discipline.
• Minimum of 7 years of work experience in a regulated environment (FDA, USDA), with pharmaceutical industry experience preferred.
• Strong proficiency in Microsoft Excel; experience with Power BI or comparable reporting tools preferred.
• Working knowledge of MS Office suite and experience with validated data systems (e.g. SAP, TrackWise, etc).
• Demonstrated ability to analyze large data sets and translate findings into prioritized actions and concise management reporting.
• Working knowledge of pharmaceutical quality-system requirements and data-integrity principles; familiarity with 21 CFR Parts 210/211 and 11, EU GMP, Annex 11, and applicable computerized-system lifecycle principles preferred.
• Experience performing quality-system assessments, record reviews, investigations, auditing, or similar objective-evidence-based evaluations.
• Willingness to travel to Perrigo locations both domestically and internationally on an occasional basis, up to 10% as business needs require.
• Excellent organizational and communication skills and an ability to work collaboratively across cultures and global time zones.

Aufgaben

• Lead the day-to-day coordination and administration of Perrigo's global quality change-management program, driving process improvement and governance.
• Administer change management governance forums, develop agendas, coordinate inputs, maintain records, and support governance sessions.
• Develop and maintain subject matter expertise in change-control processes, QMS workflows, governance model, and system controls.
• Maintain metrics, dashboards, scorecards, and management reporting to assess QMS change control process health.
• Perform surveillance of global and local change control portfolios to identify aging workflow states and barriers to progression.
• Partner with site Quality, Regulatory Affairs, Operations, Supply Chain, R&D, IT, and other functions to strengthen visibility and execution across the change lifecycle.
• Participate in evaluation and implementation of new QMS system technologies for future state standardization.
• Translate process requirements into practical system configurations; participate in design, testing, data review, migration readiness, and implementation.
• Draft, revise, route, and maintain global change-management policies, procedures, and supporting tools.
• Coordinate cross-functional improvement initiatives arising from governance reviews and audits to improve program effectiveness.
• Train employees in quality expectations related to GMP.

Kenntnisse

Excel

Power BI

MS Office

Data analysis

Ausbildung

Bachelor's degree in a scientific, engineering, data science, or related discipline

Tools

SAP

TrackWise

Jobbeschreibung

Perrigo in Allegan, MI is hiring a Corporate Quality Systems Change Control Specialist to drive the global quality change-management program. You will coordinate governance meetings, develop SOPs, and partner with Quality, Regulatory Affairs, Operations, IT, and other functions to ensure compliant change lifecycle execution.

The role emphasizes data-driven decision making, QMS process optimization, and applicable GMP standards across global sites. Travel up to 10% may be required.