Global QA Senior Manager, Medical Devices &… at Ferring · Kiel

Global QA Senior Manager, Medical Devices & Drug/Device Combined Products Location: East Kilbride, United Kingdom Job Description: At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world. Our Technical Operations division develops, manufactures and supplies high-quality products so our patients can live better lives. Creating and delivering life-changing products means getting it right first time is a shared responsibility, so our global manufacturing teams work closely together to ensure quality, accuracy and safety at all times. That means a culture of empowerment, where speaking up is valued, and growth and development are constant. Ferring+You As Global QA Senior Manager, Medical Devices & Drug/Device Combined Products, you will lead Major Global QA Medical Device projects, and you will support the Ferring Manufacturing sites as main point of contact regarding Medical Devices and device constituents of combination/medicinal products. The role may require travel of approximately 10–20% of your time, mainly within Europe. Your day at Ferring As part of the Global QA Medical Device Organization, you will: Contribute to QMS improvements for medical device and device constituent of combination products and support ISO 13485, MDSAP & MDR certification. Own key Medical Devices Process/SOPs. Ensure the corporate QMS for device activities at Manufacturing Sites, in Operation and in Central functions is implemented. Support the Manufacturing sites dealing with Medical Devices and Combination Products (by providing guidance, coordination and escalation on topics such as complaints, Deviation/CAPA, Change Request, vendor assessments or during audits Notified Bodies, FDA and Competent Authorities). Support the Commercial Medical Devices/Combination Products Projects as QA representative, ensure inputs from sites are considered and transfer properly organized. Lead assigned GQA Projects and audits. Behind our innovation…There’s you Nice to have a scientific degree, preferably Master (pharmacy, chemistry, biology or equivalent). 10 years of experience in the Pharmaceutical and Medical Device Industry (development, manufacturing, packaging, QC, QA) and cGMP environment or equivalent. Standards such as 21 CFR part 4, part 820, MDR and ISO13485 regulations (MDSAP is a plus). Design control / Design & Development process for Medical Devices and Drug/Device Combination product, Experienced in Project Management. Vendors/Customers relationships and you have the ability to set up links between external and internal partners. Medical Device / Durg Device Combination Product company auditing (as a lead auditor). You are accountable, collaborative and entrepreneurial, with a curious mindset. People come first at Ferring Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love. Our inclusive support package – “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role. Subject to a minimum period of employment at Ferring. Subject to a minimum period of employment at Ferring. Parental leave for both birthing and non-birthing parents. Extended support on family building journey. Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions. Imagine the power of your career when it’s Ferring + You. Behind our purpose… There’s you If our mission and your vision are aligned, please apply! We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status. Note to agencies: this search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us spontaneous profiles. Location: Ferring Controlled Therapeutics UK Additional Locations: Kiel, Germany