Associate Director Corporate Quality Programs

Description Overview

We are excited to be recruiting for a dedicated Corporate Quality Programs, Associate Director, to join our Corporate Quality Systems team based in our Allegan Michigan, location. This position will suit an experienced pharmaceutical industry quality professional who is seeking a new challenge and has the desire to make a difference. You will be responsible for global alignment in Quality Management System (QMS) programs.  This position reports to the Director, Corporate Quality Systems and will collaborate closely with all functions of the business.

This is a hybrid position, working three days onsite and two days remote. The role can be based out of either our Allegan or Grand Rapids corporate office.

Scope of the Role

• Establish, improve and align the core Perrigo Quality QMS programs, (global change control, deviation event handling, corrective and preventative action program, as example), to ensure compliance with regulatory and corporate standards.
• Author, revise and maintain the policies and standard operating procedures (SOPs) that govern the enterprise level Quality Management System (QMS)
• Lead global QMS harmonization efforts, perform gap assessments and current state mapping, develop remediation action plans, to drive to a corporate standard.
• Help establish QMS program standard and/or best practice for the enterprise based  on contemporary industry practice, knowledge and experience and research to drive continuous improvement and reduce regulatory risk.
• Support the internal audit process to ensure compliance with government regulation and industry/corporate policies.
• Track improvement actions and monitor performance metrics on the health of the Perrigo QMS.
• Assist in the evaluation and implementation of new QMS system technologies, which may be determined suitable for future state standardization. growth and platform modernization.
• Identify opportunities for process improvement to increase efficiency and remediate gaps in QMS systems/programs enterprise wide.
• Train employees in quality standards, procedures and core QMS elements related to GMP (Good Manufacturing Practices)

Experience Required

• Bachelor’s degree in engineering, or scientific discipline                 
• Minimum of 15 years of work experience in a regulated environment (FDA, USDA), preferred pharmaceuticals.
• Experience in quality auditing and working knowledge of quality system regulations, (GxP, 21CFR Part 11, EU Annex 11, ICH, GAMP)
• Computer skills, Microsoft Office, electronic documentation systems and ERP systems (TrackWise, OpenText Documentum, SAP)
• Proven ability to effectively operate in a matrix organization, lead 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 (20-30% of time)
• Excellent communication skills and an ability to work collaboratively across cultures and global time zones.