Job Description

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, ACO, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to win in self-care.
Description Overview
In this position you will contribute to the development and effectiveness of the QMS of Perrigo CSCI entities, to ensure compliance with public health regulations, which involves a number of various tasks.
Scope of the Role

• Leading the qualification and quality audit processes for Contract Research Organizations (CROs) and other critical partners, primarily based on Good Clinical Practice (GCP), to enhance quality oversight and avoid potential future issues in clinical studies. CROs are mainly located in Europe, with some in the US
• Handling dysfunctions according to established SOPs
• Coordinating the annual internal audit schedule
• Support the continuous improvement of the Quality Management System (QMS) of Perrigo CSCI entities
• Implement, promote and enhance the QMS within Perrigo CSCI entities
• Provide quality support in the quality documentation management process under the company's eDMS
• Provide expert advice in managing quality documentation through the company's electronic Document Management System (eDMS)
• Conduct quality training sessions for new employees.

CRO Audits:

• Perform follow-up audits during the course of clinical studies, for approximately 10 studies per year, focused on cosmetics and medical devices.
• Conduct qualification audits of CROs, primarily for commercial products (eventually for IMPD), after the involvement of the first patients.
• Systematically conduct final audits at the end of each study
• Review Standard Operating Procedures (SOPs) during the qualification process and ensure their effective application
• Review and manage Corrective and Preventive Actions (CAPAs) following audits

Dysfunctions (Mishaps):

• Manage the general dysfunction management process
• Collect, investigate, and record dysfunctions
• Implement actions associated with internal dysfunctions

Experience Required

• Ideally at least five years experience in Quality Assurance and Quality Management systems
• Experience in Quality in the Pharmaceutical or Medical Device Industry
• ISO13485/ and ISO22716
• Knowledge of GCP GMP and GDP
• Fluency in English is mandatory, fluency in French is appreciated but not obligatory

Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about at Perrigo.
Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.
We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo