Corporate Quality Systems, Change Control Specialist

Perrigo•Allegan Township, MI

1d•Onsite

About The Position

Perrigo is seeking a Corporate Quality Systems, Change Control Specialist for its Corporate Quality Systems team in Allegan, Michigan. The role supports global alignment of Quality Management System (QMS) programs, particularly the global change-control program. It is responsible for coordinating and administering the program, supporting process improvement and governance, and helping ensure compliance with regulatory and corporate requirements. The position reports to the Associate Director, Corporate Quality Systems and collaborates with functions across the business. The specialist administers global change-control governance forums, maintains process metrics and reporting, monitors change-control portfolios, and works with site Quality, Regulatory Affairs, Operations, Supply Chain, R&D, IT, and other teams. The role also contributes to QMS technology evaluation and implementation, process and system design, documentation, training, and cross-functional improvement initiatives. Occasional domestic and international travel to Perrigo locations may be required, up to 10% as business needs require.

Requirements

Bachelor's degree in a scientific, engineering, data science, or related discipline.
At least 7 years of work experience in a regulated environment, such as FDA- or USDA-regulated work.
Strong proficiency in Microsoft Excel and working knowledge of the MS Office suite.
Experience with validated data systems, such as SAP or TrackWise.
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.
Experience performing quality-system assessments, record reviews, investigations, auditing, or similar objective-evidence-based evaluations.
Ability to support projects and teams, influence without direct authority, interact with senior leaders, and work independently and proactively toward goals.
Willingness to travel occasionally to Perrigo locations domestically and internationally, up to 10% as business needs require.
Excellent organizational and communication skills and ability to collaborate across cultures and global time zones.

Nice To Haves

Pharmaceutical industry experience.
Experience with Power BI or comparable reporting tools.
Familiarity with 21 CFR Parts 210/211 and 11, EU GMP, Annex 11, and applicable computerized-system lifecycle principles.

Responsibilities

Coordinate and administer Perrigo's global quality change-management program, supporting process improvement, global harmonization, governance execution, and compliance with regulatory and corporate requirements.
Administer governance forums for the global change-control system, including preparing agendas and meeting content, coordinating presenters and inputs, maintaining governance records and decision history, and supporting working sessions.
Maintain subject matter expertise in change-control processes, QMS workflows, governance, system controls, and related business processes.
Maintain metrics, dashboards, scorecards, and management reporting to assess process health, track actions and improvement initiatives, identify risks and trends, and support data-driven decisions.
Conduct routine surveillance of global and local change-control portfolios to identify aging workflows, stalled records, inactive assignments, and barriers to progression or closure.
Partner with site Quality, Regulatory Affairs, Operations, Supply Chain, R&D, IT, and other functions to improve visibility, accountability, and execution across the change lifecycle.
Participate in evaluating and implementing QMS system technologies for potential future standardization, growth, and platform modernization.
Help translate process requirements into practical system configuration and participate in process design, testing, data review, migration readiness, and implementation.
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, metrics, audits, inspections, system enhancements, and business priorities.
Train employees in quality expectations related to core QMS elements and Good Manufacturing Practices (GMP).