Job Description

IMP Quality Manager (m/f/d) - pharmaceutical / cGMP/ SOPs, master batch records, discrepancy and change records and validation reports / parenteral IMPs (e.g. EU Annex 1) / CAPA/ Veeva Vault/ SAP/ MES/ LIMs / English / German
Project:
For our customer a big pharmaceutical company in Basel we are looking for IMP Quality Manager (m/f/d).
Background:
IMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products ("IMPs") to our patients in compliance with cGMP. We are the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and Compliance oversight of all.
Our purpose is to create a space for experimentation by coaching and celebrating learnings to build a purpose driven quality community that delivers innovative medicines to patients. This position within IMP Quality Operations Switzerland requests a high level of flexibility, ability to work under pressure and sense of responsibility. If you have detailed knowledge of GMPs as well as outstanding interpersonal and negotiating skills, you should apply for this job...
The perfect candidate has a solid Quality Assurance knowledge and experience in GMP compliance for sterile drug product manufacturing and quality control.
Tasks & Responsibilities:

• Acts as a delegate of the Swiss RP for IMPs
• Has the QA responsibility for GMP compliance of manufacture and analysis of IMP batches (in particular parenteral drug product batches).
• Reviews and approves GMP procedures, records and reports (e.g. SOPs, master batch records, discrepancy and change records and validation reports).
• Performs self-inspections in GMP plants and laboratories at Roche Basel.
• Reports directly to the RP and RP deputy..

Must Haves:

• Bachelor or Master Degree in Life Sciences or equivalent.
• Min. 3 years of relevant experience in the pharmaceutical industry.
• Min. 3 years experience in a GMP regulated environment.
• Min. 3 years experience all activities around parenteral manufacturing and quality control.
• Demonstrated experience in a Pharmaceutical Technical Development environment.
• Knowledge of cGMP and Quality requirements for clinical development stages of biotechnological and/or parenteral IMPs (e.g. EU Annex 1).
• Experience in Discrepancy Management, CAPA, Technical Change Management (Veeva Vault) and Manufacturing Management (SAP), MES (PMX) and LIMS is an additional plus.
• Ability to communicate clearly and professionally both verbally and in writing in English (C1) as well as in German (C1).

Soft skills:

• 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.

Nice to Have:

• Project management skills
• Proficient contribution to health authority inspections and internal GMP audits

Reference Nr.:SDA
Role: IMP Quality Manager (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum:% (Home Office 20 %)
Start :( latest Start Date:)
Duration: 12 ++
Deadline: 17/06/2025
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme:
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees. jidfd37f90a jit0624a jiy25a