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QA Manager - Biologics - CMO Management

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Our customer is a US-based biopharmaceutical company with an exciting pipeline in oncology going into late phase clinical trials. Beside its own research, the company offers a technology platform and…

QA Manager - Biologics - CMO Management
6 months Contractor - deputy QP – CMC - Basel
 
Our customer is a US-based biopharmaceutical company with an exciting pipeline in oncology going into late phase clinical trials. Beside its own research, the company offers a technology platform and develops numerous successful partnerships for state-of-the-art pharmaceutical drug formulations and applications.A European Hub has been successfully set up in Basel three years ago. Now we seek support for the QA group. This role is meant to support QA/QC activities at Contract Manufacturing Organizations (CMO) in the DACH region. As part of the international QA Team, you are responsible to support GMP compliance at CMOs developing and supplying biological drug substances and drug products in various formulations.You provide expertise to support QA operations, manage and execute Master Batch Record Reviews, and execute Batch Record Reviews and Approvals. In addition, you accompany external audits and vendor qualifications, give input in  the respective risk assessments, write audit reports, and act as representative at CMOs for partner audits. You are involved in the preparation, revision and/or reviewing of CMC sections of world-wide regulatory filings such as IMPD/IND/CTD/BLA, supplements, amendments and other submissions as needed.Your profile:
  • Life Science degree in Biochemistry, Biotechnology, Pharmacy or related
  • + 5 years of experience in QA (Bio)Pharmaceutical Operations
  • Experience required in DS, DP (sterile f-f), packaging/labelling operations
  • Proficient in the interpretation of US and EU GMP regulation
  • Ability to balance quality decisions, business implications and technical considerations
  • Experienced in influencing and leading external partners
Experience in both biologic drug substance and drug product is an asset. A key success factor will be your influence capability to enforce quality decisions at suppliers. Exceptional negotiation skills, good German and English communication and presentation skills are key requirements for this role in order to develop strong business partnerships with both internal and external stakeholders. The position requires travelling in European countries (DACH region) - estimated around 20%. The role might lead to a perm engagement, dependent on the success of clinical results!

Interested? We are looking forward to get in touch with you.

Adresse

gloor & lang ag life science careers
Herr Luca Rohr
Associate Consultant
Bahnhofstrasse 31
5400 Baden
+41 61 206 61 81

Website http://www.gloorlang.com

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