Global QA Senior Manager, Medical Devices & Drug/Device Combined Products

Global QA Senior Manager, Medical Devices & Drug/Device Combined Products

Ferring Pharmaceuticals

East Kilbride, United Kingdom or Kiel, Germany

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/Drug Device Combination Product company auditing (as a lead auditor);
• You are accountable, collaborative and entrepreneurial, with a curious mindset.