Manager – Quality operations and Deputy Responsible Person

Job Summary

• This position has primary responsibility to ensure that the Medicinal Products traded by FKSBS Business Unit (BU) Pharma & Nutrition are in continuous compliance with applicable law and regulations (GxP, ICH, ISO especially ISO9001).

• Act as deputy Responsible Person (RP), Manage the GDP-related quality tasks and support the GMP activities for commercial Medicinal Products traded by FKSBS BU Pharma & Nutrition.

• Responsible for managing, maintaining and overseeing all quality-related processes associated with foreign trade business in collaboration with the relevant Business Units, the Production Units, the Suppliers, the Market Units and/or Regions, for existing products and new launches.

• Contribute to the maintenance of Quality Systems related to the Swissmedic Establishment Licenses for Import, Export, Wholesale and Foreign Trade of Medicinal Products, ensuring continuous compliance with the Swiss Therapeutic Products Act (TPA), the EU GDP and any other applicable regulations.

• Manage the applicable GDP quality tasks and support the GMP activities to trade  Medicinal Products for BU Pharma & Nutrition.

• Maintain an up-to-date knowledge of cGxP regulations and applicable standards (especially in the US and EU) and support implementation of requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc.).

• Act as deputy RP, i.e. support the GxP activities for commercial medicinal products traded by FKSBS; support the RP for the GDP-related quality tasks; contribute to the maintenance of Quality Systems related to the Swissmedic Establishment Licenses.

• Support FKSBS BU Pharma & Nutrition and TPMs due diligence & suppliers qualification activities, including managing Quality Agreements and conducting Audits.

• Oversee the collection and processing of Events, Changes, CAPAs liaising with the relevant functions of the respective Business Unit, other Fresenius Kabi entities and Suppliers. Notify management of events requiring immediate attention/action.

• Develop and Collect Key Quality/Compliance Indicators for periodic review of local Quality management system and regular communication with Supply Chain.

• Contribute to continuous improvement of quality processes associated with Medicinal Products, such as, but not limited to, inspection readiness, internal & external audits, supplier management, documentation, changes / events, CAPAs, management reviews, recalls.

• Identify training needs for the BU Pharma & Nutrition team at FKSBS.

• Contribute to internal audits, self-inspections and Health Authorities inspections.

• Support GMP / GDP / MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers.

• Manage the Quality Management Reviews for BU Pharma & Nutrition.

• A BA/BS, MA/MS in a scientific discipline or related field.

• 5 years' experience in a Quality function with increasing levels of responsibility in pharmaceutical industry, preferably in areas related to production.

• Strong understanding and interpretation of GMPs, GDP, ICH guidelines and quality best practices regarding manufacturing & distribution processes.

• Significant experience as lead auditor for pharmaceutical manufacturing processes.

• Experience with regulatory agencies such as Swissmedic, EMA, FDA etc.

• Prior experience as deputy Responsible Person & interactions with Swissmedic is an asset.

• Fluency in English; German and/or French would be beneficial.

• Demonstrated ability to work effectively in a team-oriented and complex matrix environment.

• Demonstrated skills in Leadership, Drive, Enthusiasm.

• Goal-Orientated/Commitment to follow up on tasks.

• Decision Making, Problem Solving, Independence.

• Flexibility and Willingness to travel (up to approx. 25%).

• Proactive and Self-motivated.