Are you ready to join an exciting journey in the world of consumer healthcare?Cooper Consumer Health is a leading European consumer healthcare player that develops, produces, and distributes a diverse range of OTC (over-the-counter) products with strong brands such as Valdispert, Oenobiol, Excilor, Vitascorbol, Lashilé and many more.Join us as we embark on an exciting phase of growth, with ambitious plans to double our business in the next 3-5 years.Today, we're currently in the midst of an exciting M&A project to acquire a large OTC portfolio. This strategic move will expand our footprint across key European markets such as France, Netherlands, Italy, Belgium, Spain and Portugal.Through this strategic acquisition, combine with our historical footprint, the Group will continue to be a pioneer in the development, manufacturing, and distribution of a diverse array of over-the-counter products. With our large portfolio, which includes now many leading brands in their area, we cater to the needs of our consumers with unparalleled excellence.At each of our markets, we operate with an entrepreneurial spirit, fostering a culture of accountability and empowerment at every level. Our 'global local' approach ensures that each of our local teams is empowered to thrive in their respective markets, supported by a network of global experts.Our values are more than just words on a page - they're the guiding principles that drive everything we do. From our commitment to empowerment and ownership to our unwavering dedication to respect, transparency, and inclusiveness, we believe in doing good to do well.If you're ready to be a part of this exciting journey, join us at Cooper Consumer Health and together, let's empower healthier lives!JOB DESCRIPTIONYou will be responsible for leading Quality Management system implementation with CMO for the group and ensuring CMOs compliance to global CCH requirements and that the products meet regulatory requirements. Your area of focus will be Medical Devices. You will manage CMO audits or visits and also the qualification process of new CMO. You will also communicate with CMOs in regards to quality requirements and work closely with Procurement, R&D and Quality in order to solve any issues.RESPONSABILITIESReport complaints to CMO for quality investigation and challenge root cause and follow up on CAPAEnsure CMO activities are fully compliant with regulatory and CCH guidelines to minimise risk to consumers, company and brand name.Recommends suspension of supply on the basis of failures in Supplier quality management systems.Quarantine of stock where there is doubt on assurance of quality, safety and efficacy of finished products to be sold.Manage CMOs in all quality related tasks and build up and maintain close relationship with CMOs.Responsible for overall Quality management system for CMOsResponsible for self-inspection program and audit readiness for corporate/external audit for the CMO under remitPerforming CMO Quality management review and CMO quality KPIs, main quality issue and improvement project/opportunitiesLead all investigations regrading defected products with the impacted CMOInsurance of CMO team compliance to corporate global, local SOPs and Electronic Quality systemsThe approval (or rejection) of new CMO/ suppliersDevelopment and maintenance of the ongoing supplier assessment and re-approval programme based on risk.Ensure 3rd party activities are fully compliant with regulatory and CCH guidelines to minimise risk to consumers, company and brand nameReview/ approve and report on monthly basis the change control and non-conformity process for CMOsEnsure Quality Technical agreements are in place and approved.Work closely with Marketing, regulatory, Procurement, Supply and and other QA personnel in markets to resolve quality issues with suppliers and contractors that may affect consumer safety, regulatory compliance, customer satisfaction and operational performance.Conduct Quality Review, document the process and report to global quality teamApprove APR for pharma productAudit and control of 3rd parties quality performance to CCH, including but not limited to finished product contractors, active ingredient suppliers, raw material and component suppliers.CAPA follow upMonitoring the quality performance of existing suppliers/contractors and their ongoing approval as a supplier to CCH.Ensure CMOs updated Site master files (SMF) and Site Validation master planLead Mock Recall/recall processes for products produced at CMOCollation of information supporting continued approval of 3rd parties and products and ensuring CCH continued confidence in the 3rd party to perform at the required standard to supply CCH.Regulatory compliance of CCH maintained with regard to suppliers and contractors.Resolution of quality issues that may affect consumer safety, regulatory compliance, customer satisfaction and operational performance.COMPETENCIES10 years of experience in quality manufacturing and CMO managementStrong QMS knowledge and product manufacturing knowledgeThorough knowledge of the regulatory and quality requirements and guidance covering the manufacture of medical devices.Experience in good manufacturing practices (GMP)Experienced auditor, ideally with Lead Auditor or similar qualification.Other informationFlexible work / home office (3 days in the office and 2 from home)#J-18808-Ljbffr
