For our client we are looking for a

QA Manager (m/f/d) 100%

The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality, Quality Systems and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.

The Clinical Supply Centre in Basel for Parenterals is responsible for manufacturing Sterile Drug Products for clinical studies. In the course of the implementation of Volume 4 EU Guidelines for GMP Annex 1 (C(2022) 5938, 22-Aug-2022) (and and PIC/S PE 009-16 GMP Guide, Annex 1), the candidate supports and drives end to end the full implementation of Annex 1 in the role as Quality Assurance Manager. The candidate collaborates in close partnership with all involved parties from the Clinical Supply Centre Parenterals.

The candidate supports and oversees the end to end cGMP activities in implementation of Annex 1 requirements at the Clinical Supply Centre Basel. They take care that the Right to Operate can be maintained by ensuring that quality and compliance requirements according to Health Authority expectations and Company Standards for IMP products are given after the successful implementation of Annex 1.

The perfect candidate has sound Quality Assurance knowledge and experience in the area of Annex 1 implementation, sterile Drug Product Manufacturing, Qualification and Validation as well as parenteral manufacturing activities.

Tasks & Responsibilities:

• Support and drive implementation of Annex 1 requirements during implementation in the Clinical Supply Centre for sterile Drug Product (Parenterals) within IMP Switzerland.
• Responsible to represent Quality Assurance while driving all activities related to a successful implementation of Annex 1 within IMP Quality Operations Switzerland
• Maintaining and continuously supporting all Qualification/Validation and parenteral manufacturing activities within IMP Quality Operation Switzerland
• Support and collaborate with Quality Assurance Managers within IMP Quality Operations Switzerland
• Provide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. SOPs, qualification, validation documents)
• Partner with all stakeholders within the Clinical Supply Centre as well as with Technical Development and provide guidance to ensure successful delivery of the Annex 1 implementation goals
• Support your area of responsibility at HA inspections and internal audits

Must Haves:

• BS/MS/PhD Degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, Pharmacy or equivalent (*****)
• 2-5 years experience in a GMP regulated environment and with Quality Systems, Quality assurance and OT (*****)
• Experience in Quality Risk Management as well as in performing risk assessments (e.g. FMEA) (*****)
• Experience in Qualification / Validation as well as all all activities around parenteral manufacturing (*****)
• Fast learner, strong team-player with a high level of self-motivation and with ability to prioritize, simplify and connect the dots.
• Proven ability to work independently and in a team towards results
• Excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems
• Experience with Annex 1 is a plus
• Experience in Discrepancy Management, CAPA, Technical Change Management is a plus
• Project management skills is a plus
• Proficient contribution to health authority inspections and internal GMP audits is a plus
• Fluent in German, English B2

General Information:

• Start date: asap
• End date: 1 year
• Extension: very likely
• Work location: Basel
• Remote/Home Office: only by exceptions
• Workload: 100%

Your Application:

Please apply online. For further information about the position, please contact your Kelly recruiter, Fatbardha Igrishta (fatbardha.igrishta[a]kellyservices.ch).