Associate Director Corporate Quality Programs

Scope of the Role

• Establish, improve and align core Perrigo Quality QMS programs (global change control, deviation event handling, CAPA) to ensure compliance with regulatory and corporate standards.
• Author, revise and maintain enterprise-level Quality Management System (QMS) policies and SOPs.
• Lead global QMS harmonization efforts: perform gap assessments and current state mapping; develop remediation action plans to drive to a corporate standard.
• Establish QMS program standards/best practices to drive continuous improvement and reduce regulatory risk.
• Support the internal audit process for compliance with government regulation and industry/corporate policies.
• Track improvement actions and monitor QMS performance metrics.
• Evaluate and implement new QMS system technologies for future standardization, growth, and platform modernization.
• Identify process improvement opportunities to increase efficiency and remediate QMS gaps enterprise-wide.
• Train employees in quality standards, procedures, and core QMS elements related to GMP.

• Bachelor’s degree in engineering or scientific discipline.
• 15+ years in a regulated environment (FDA/USDA), preferred pharmaceuticals.
• Quality auditing experience and working knowledge of quality system regulations (GxP, 21 CFR Part 11, EU Annex 11, ICH, GAMP).
• Computer skills (Microsoft Office), electronic documentation systems, and ERP (Track Wise, Open Text Documentum, SAP).
• Ability to operate in a matrix organization; lead projects/teams; influence without authority; work independently and proactively.
• Travel 20–30% domestically and internationally.
• Excellent communication; collaborate across cultures and global time zones.

Competitive compensation; benefits for you and your family; career development.