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Corporate Quality Systems, Change Control Specialist
Perrigo Company plc. Lead the day-to-day coordination and administration of Perrigo’s global quality change-management program .
About the role
Key responsibilities & impact- Lead the day-to-day coordination and administration of Perrigo’s global quality change-management program
- Drive process improvement, global harmonization, governance execution, and compliance with regulatory and corporate requirements
- Administer governance forums for Perrigo’s global change control system
- Develop meeting agendas and content, coordinate presenters and inputs, maintain governance records and decision history, and support focused working sessions
- Maintain subject matter expertise in change-control processes, QMS workflows, governance models, system controls, and associated business processes
- Maintain metrics, dashboards, scorecards, and management reporting to assess QMS change-control process health and track actions and initiatives
- Perform surveillance of global and local change-control portfolios to identify aging workflow states, 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 across the change lifecycle
- Participate in evaluation and implementation of new QMS system technologies
- Support 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, metrics, audits, inspections, system enhancements, and business priorities
- Train employees in quality expectations related to core QMS elements and GMP
Requirements
What you’ll need- 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
- Experience with validated data systems such as SAP and 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
- 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
- Ability to support projects and teams, influence without direct authority, interact with senior leaders, and work independently and proactively
- Willingness to travel to Perrigo locations domestically and internationally on an occasional basis, up to 10% as business needs require
- Excellent organizational and communication skills
- Ability to work collaboratively across cultures and global time zones
- All application materials, including resumes and CVs, must be submitted in English
Benefits
Comp & perks- Competitive compensation
- Benefits tailored to supporting you and your family
- Career development opportunities
- Inclusive, collaborative culture
- Equal opportunity employment