Overview
Quality Assurance Compliance Manager Jobs in Basel, Basel, Switzerland at Randstad Switzerland
Title: Quality Assurance Compliance Manager
Company: Randstad Switzerland
Location: Basel, Basel, Switzerland
For our client, a leading international pharmaceutical company in Switzerland, we are seeking a QA Manager Compliance, Systems and Inspections.
General Information:
Start date: ASAP
Latest possible start date: 01.06.2025
Duration: unlimited
Workplace: Basel
Workload: 80-100%
Department: IMP Quality Operations
Working hours: Standard
Home office: required on site, home office possible by arrangement
About the job:
IMP Quality Switzerland (Investigational Medicinal Product) is part of Quality Organization and is responsible for QA oversight of all manufacturing facilities and support functions in Basel and Kaiseraugst that produce drug substances, drug products and blinded investigational medicinal products for clinical trials.
The ideal candidate has an academic background in the natural sciences and more than 5 years of experience in the pharmaceutical industry, in particular with inspections in a GMP regulated environment. Ideally, the person has experience in coordinating inspections and liaising with Swissmedic. The person brings extensive experience in GMP inspections and is familiar with Swissmedic’s cGMP requirements. Experience in the manufacturing, analysis, and release of drug substances and drug products from IMPs is required.
Tasks and responsibilities:
End-to-end support of GMP inspections
Proactive preparation of inspections for all IMP areas Basel/Kaiseraugst (organization and technical support of the SMEs)
Active role in the inspection (front office/back office)
Follow-up of the inspection (response process, follow-up of the measures)
Ensuring the timely and compliant fulfillment of all commitments to the health authorities
Interface to the Manufacturing network with regard to GMP inspections for holistic and proactive inspection preparation
Support of the self-inspection program
Support in the implementation of Data Integrity (DI) requirements
Support of the QMS Business Process Managers in Quality Systems matters
Responsible for the management and optimization of initiatives and improvements within IMP Quality Switzerland.
Partnership with stakeholders and collaboration to successfully implement IMP objectives
Communication and matrix leadership during GMP inspections
Must Haves:
Academic degree in natural sciences (pharmacy, chemistry or equivalent)
Min. 5 years of professional experience in the pharmaceutical industry, in particular the production of drug substance, drug product and finished product
Min. 5 years of professional experience in GMP inspections of health authorities and the current expectations of Swissmedic
Excellent knowledge of global quality and GMP requirements
Sound understanding of current data integrity requirements
Strong team player with high self-motivation and the ability to effectively influence others across all organizational levels
Strong communication and matrix leadership within the framework of GMP inspections
Fluent German and very good English skills are mandatory for this position
Does this sound interesting to you? Apply now – we look forward to receiving your application!
