Project: For our client, a large pharmaceutical company based in Basel, we are looking for a Quality Assurance Manager (m/f/d).
Background:
The Basel Drug Substance division at the Group headquarters in Basel is divided into various production units for monoclonal antibodies (MAB), single-use technology (SUT), and antibody drug conjugates (ADC). Within this dynamic environment, the Quality Assurance (QA) team ensures compliance with the highest quality standards and drives continuous process improvement. Organizationally, the QA managers belong to one of the two QA Operations Chapters (MAB or ADC&SUT).
As Quality Assurance (QA) Managers at Basel Drug Substance, QA Managers make a crucial contribution to quality oversight across the entire production unit. In this role, they are responsible for ensuring compliance with and continuous optimization of the quality system, always taking into account current legal and internal Roche requirements. Through changing assignments, they expand their network and actively contribute to process harmonization.
The ideal candidate has a university degree in a scientific or engineering field (e.g., biology, chemistry, pharmacy, biotechnology) and at least 3-5 years of professional experience in quality assurance or GMP compliance. Experience in the manufacturing of biotechnological active ingredients is required, as is at least 3 years of professional experience in a GMP-regulated environment.
Tasks & Responsibilities:
* Central contact person for the production facilities for all quality issues, from production from raw material release to validation.
* Ensuring quality oversight and GMP compliance in the managed productions and projects.
* Reviewing, assessing, and approving manufacturing documentation, both on paper and in the electronic Manufacturing Execution System (MES).
* Responsible for the release of manufactured active ingredients.
* Processing, assessing, and approving deviations, corrective actions (CAPAs), and technical change requests.
* Conducting quality floor walks and self-inspections, and supporting internal audits and regulatory inspections.
* Actively contributing ideas for continuous process improvement and supporting their implementation.
Must Haves:
* Completed university degree in a scientific or engineering field (e.g., biology, chemistry, pharmacy, biotechnology)
* At least 3-5 years of professional experience in quality assurance or GMP compliance, in the production of biotechnological active ingredients.
* At least 3 years of experience in a GMP-regulated work environment.
* Strong team player with excellent communication skills.
* High quality awareness and an independent, results-oriented, and assertive working style.
* Fluent communication in German and English (spoken and written)
* Proficient in the use of common IT systems in the pharmaceutical industry.
Reference No.: 924495
Role: Quality Assurance Manager (m/f/d)
Industry: Pharma
Location: Basel
Workload: 80-100%
Start: 01/01/2020
Duration: 9++ months
Application deadline: 22/10/2025
Job Type: 80-100%
Work Location: On the road