Associate Director Corporate Quality Programs
Perrigo Company plc
4 months ago
Remote friendly (Allegan, MI)
United States
Corporate Functions
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.
Experience Required:
- 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 (TrackWise, OpenText 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.
Benefits:
- Competitive compensation; benefits for you and your family; career development.
Application Instructions:
- Click the APPLY button at the bottom of the application; submit all materials (resumes/CVs) in English.
- 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.
Experience Required:
- 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 (TrackWise, OpenText 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.
Benefits:
- Competitive compensation; benefits for you and your family; career development.
Application Instructions:
- Click the APPLY button at the bottom of the application; submit all materials (resumes/CVs) in English.