IMP Quality Manager (f/m/d)

IMP Quality Manager (f/m/d) – cGMP / clinical / development / german / english

Project:
For our pharma client in Basel are we looking for a highly qualified IMP Quality Manager.

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 in order to build a purpose driven quality community that delivers innovative medicines to patients. The roles are: Quality Assurance (QA) Manager for IMPs in Pharma Technical Quality (PTQ) having the end-to[1]end product quality oversight. Quality Single Point of Contact (QSPOC) for IMPs until PivGo is a strategic role working cross[1]functionally for the assigned molecules and partners with the TDT and IMPQ LT to implement a product quality strategy.

The perfect candidate:
Has a PhD in Life Sciences and 5 years experience in the pharmaceutical industry. The person is familiar with the Pharmaceutical Technical Development environment, cGMP, as well as Quality requirements for clinical development stages. Lastly, the candidate is proficient in English and German.

Tasks & Responsibilities:

The role of IMP QA Manager is assigned as a delegate of the Swiss Responsible Person for IMPs in Basel and:
– responsible for the lot disposition of IMP e.g. bulk drug product materials and active pharmaceutical ingredients (API)
– ensures that the quality of the produced IMPs, manufactured by Technical Research and Development (TR&D) Basel, is in accordance with cGMP regulations
– actively participates in compiling, reviewing and approving of Pharma Quality System(PQS) standards
– reviews and approves documents, e.g. Production Records, methods and specifications, change control documents, risk assessments, deviations and investigations
– participates in internal as well as in external audits In the role of Q-SPOC you:
– act as a single point of contact for the Technical Development Teams for Early State Products
– lead the Quality Sub Team consisting of all IMP relevant QA functions are responsible to identify and communicate significant quality risks as well as to drive risk mitigation plan

Must Haves:

– Master degree or PhD in Life Sciences or similar degree
– Minimum 5 years of relevant experience in the pharmaceutical industry
– Demonstrated experience in a Pharmaceutical Technical Development environment (Small or Large Molecules or New Modalities)

– Knowledge of cGMP and Quality requirements for clinical development stages
– Strong leadership, communication and influencing skills

– Ability to communicate clearly and professionally both verbally and in writing in English as well as in German

Reference Nr.: 922449SKN
Role: IMP Quality Manager
Industrie: Pharma
Workplace: Basel
Pensum: 80-100%
Start: 01.04.2023
Duration: 12++
Deadline: 06.03.2022

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: +41 41 760 77 01.

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.