GCP Auditor

Quality Minneapolis, Minnesota


Description

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

The Auditor plans, schedules, conducts and follows up on GxP Audits of Perrigo Sites, Material Suppliers, Contract Operations or Contract Service Providers to assure Perrigo and its business partners comply with applicable cGxP.  The Auditor applies appropriate GxP standard based on location / where marketed and function and depending on expertise may lead GCP (clinical), GDP (distribution), GLP (laboratory), GMP (manufacturing) or GPvP (Pharmacovigilance) audits to US FDA, MHRA, EMA, TGA or other local regulatory authority standards.   This person also leads or participates in assigned projects to establish or improve corporate audit and/or quality compliance governance processes to assure robust processes met stakeholder expectations.

Requirements and Qualifications:

  • Bachelor’s degree in a scientific discipline or closely aligned field
  • Ten (10) or more years of experience in GxP regulated industry strongly preferred, at least six (6) years of which is in GxP audit / compliance required
  • Quality Auditor designation/certification preferred
  • Requires significant domestic and international travel (approximately 60%)
  • Must possess thorough understanding of, and ability to interpret, GxP regulatory requirements relative to one or more country/region that Perrigo operates or markets product
  • Subject matter expertise in one or more area of GxP (e.g. GMP, GCP, GLP, GPvP) relative to medical and/or nutritional product development, manufacturing and/or supply chain
  • Strong analytical and interpersonal skills, commanding oral and written communication ability
  • Self-directed and able to work effectively across multiple global cultures in a matrix environment
  • Ability to influence management, peers and other colleagues without direct reporting lines
#DIV

 

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.