Release & QP Team Lead

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®, 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 The Release and Qualified Person (QP) Lead will be accountable for providing strong Quality Assurance oversight of commercial finished pharmaceutical products. This role is responsible for quality oversight and batch certification of finished products within the scope of the company’s Manufacturing and Importation Authorisation (MIA), as well as for fulfilling all statutory duties of the Qualified Person in accordance with applicable EU regulations. The role will ensure stakeholder management and communication on prioritise throughout the business. Scope of the Role Ensure that each batch of commercial product manufactured and/or packaged has been checked for compliance with the Marketing Authorisation or Product Licence, EU GMPs and the requirements of the Quality Technical Agreements in place with Contract Giver, prior to QP certification of each batch. Ensure that each batch of investigational medicinal product manufactured and/or packaged has been checked for compliance with the Product Specification File and/or IMPD, EU GMPs and the requirements of the Quality Technical Agreements in place with Contract Giver, prior to the QP certification of each batch. Review and approve Annual Product Reviews/Product Quality Reviews. Attend meetings, initiating QP related discussions for new or ongoing business and offering advice on questions, as appropriate. Provide QP support to internal project teams. Represent the Quality Department during customer audits, regulatory inspections and customer visits. Review and approve Quality Technical Agreements with Contract Givers and Perrigo Pharma Services Contract Acceptors, who provide support services to facilitate the QP certification of products. Provide input into the development and maintenance of the Pharmaceutical Quality System. Ensure appropriate QP oversight of the Pharmaceutical Quality System by reviewing Key Performance Indicators related to its operation. Review and approve key quality system documentation, such as change requests, deviation reports, suspect analytical result investigations and product complaint investigations. Review and approve (as applicable) Perrigo policies, guidelines, procedures and specifications. Provide QA/QP input into risk management programmes and quality system initiatives running within Perrigo. Ensure stakeholder engagement. Follow up on queries which may impact on product quality with internal and/or external contacts as required. Participate in the internal and external audit schedules. Host Regulatory Authority audits and ensure preparation of such audits is actioned. Stay current with legislation, guidelines and other expectations of the pharmaceutical industry especially in relation to GMP, Quality Management and QP responsibilities including ensuring reports are also engaging in their development and knowledge of changes in regulations. Experience Required Bachelor’s degree in Pharmacy, Chemistry, or Life Sciences. A minimum of 10+ years experience in quality assurance/control within the pharmaceutical industry. QP Status: Must meet educational and experience requirements specified in Directive 2001/83/EC Prior experience as a named Qualified Person (QP) at a licensed facility for several years Previous people management experience Strong working knowledge of cGMP in manufacturing and testing environments Clear, accurate technical and compliance-focused writing skills Experience supporting regulatory inspections and internal GMP audits preferred Proven ability to manage stakeholders and escalate issues appropriately 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 Total Rewards 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 here 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.) All application materials, including resumes and CVs, must be submitted in English. 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