Corporate Quality Systems, Change Control Specialist

Description Overview

We are seeking a dedicated Corporate Quality Systems, Change Control Specialist, to join our Corporate Quality Systems team based in our Allegan, Michigan, location. This position is well-suited for a pharmaceutical industry quality professional who is seeking a new challenge and an opportunity to make a meaningful difference. You will be responsible for global alignment in Quality Management System (QMS) programs, specifically supporting the global change control program, a core QMS capability. This position reports to the Associate Director, Corporate Quality Systems and will collaborate closely with all functions of the business.

If you want to have a positive impact while working alongside brilliant people, then read on….

Scope of the Role

• Lead the day-to-day coordination and administration of Perrigo's global quality change-management program, driving process improvement, global harmonization, governance execution, and compliance with regulatory and corporate requirements under the direction of the Associate Director, Corporate Quality Systems.

• Administer change management governance forums for Perrigo’s global change control system, which will include developing agendas and content for periodic governance meetings, coordinating presenters and inputs, maintaining governance records and decision history, and supporting focused working sessions between formal governance meetings.

• Develop and maintain subject matter expertise in Perrigo's change-control processes, QMS workflows, governance model, system controls, and associated business processes.

• Maintain metrics, dashboards, scorecards, and management reporting to assess QMS change control process health, track governance actions and improvement initiatives, identify emerging risks and trends, and support data-driven decision making across the organization.

• Perform routine surveillance of global and local change control portfolios to identify aging workflow states, stalled records, inactive assignments, and preventable barriers to record progression or closure.

• Partner with site Quality, Regulatory Affairs, Operations, Supply Chain, R&D, IT, and other functions to strengthen visibility, accountability, and execution across the change lifecycle.

• Participate in the evaluation and implementation of new QMS system technologies, which may be determined suitable for future state standardization, growth and platform modernization.

• Help ensure that process requirements are translated into practical system configuration. Participate in process design, testing, data review, migration readiness, and implementation activities.

• Draft, revise, route, and maintain global change-management policies, procedures, work instructions, process maps, forms, training materials, governance documents, and supporting tools.

• Coordinate cross-functional improvement initiatives arising from governance reviews, health metrics, audits, inspections, system enhancements, and business priorities to improve the effectiveness of the global change-management program.

• Train employees in quality expectations central to core QMS elements related to GMP (Good Manufacturing Practices) .

Experience Required

• 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.

• Proven ability to support projects and teams, influence without direct authority, interact with senior leaders and work independently and proactively in the completion of goals.

• 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.