For our client, a leading company in the pharmaceutical sector, we are seeking a Technical QA Manager to support quality operations for investigational medicinal products (IMPs). This is a temporary role offering the opportunity to contribute to cutting-edge pharmaceutical development within a GMP-compliant environment. The perfect candidate is someone with an academical natural science background and 10+ years of experience in the pharmaceutical industry and 5 years in QA. The candidate also brings a broad experience in Qualification/Validation related to Synthetic Molecules Manufacturing and/ or Quality Control. A deep technical understanding of pharmaceutical production is required. Experiences in Biotech production is a plus.

General Information:

* Start date: asap

* latest Start Date: 1.4.2025

* Planned duration: 12 months contract via Randstad

* Extension: very likely

* Workplace: Basel

* Workload: 100%

* Remote/Home Office: Onsite required, home office upon discussion

* Travel: no

* Working hours: Standard

Tasks & Responsibilities:

• QA supervision of qualification- and validation-activities for GMP-relevant equipment for Synthetic Molecule production and/or Quality Control.
• Ensure QA oversight and establish guardrails for operational facilities regarding GMP and Quality standards.
• Support implementation of Data Integrity (DI) requirements.
• Provide technical and quality assurance expertise for reviewing and approving quality-related documents, including Qualification Plans, Reports, Change Management, CAPAs, SOPs, Risk Analysis, and others.
• Facilitate or act as an expert in deep root cause analyses to independently address and resolve complex issues.
• Drive optimization activities and improvements within Quality Operations.
• Partner with stakeholders to ensure successful delivery of goals for investigational medicinal products (IMPs).
• Represent and support your area of responsibility during health authority inspections and internal audits.
• Support end-to-end cGMP activities to maintain compliance with Health Authority requirements and company standards for IMP products.

Must Haves:

• Academic degree in Engineering, Chemistry, Life Science, Pharmacy, or equivalent.
• Significant experience in the pharmaceutical industry, with a strong focus on Qualification/Validation of equipment for synthetic molecules manufacturing and/or Quality Control.
• Solid understanding of current Data Integrity (DI) requirements.
• In-depth knowledge of global quality and GMP standards.
• Proven ability to perform successfully in health authority inspections and internal GMP audits.
• Excellent team player with self-motivation and strong influencing skills across organizational levels.
• Fluent in German and English (spoken and written).

Nice to Have:

• Strong communication skills with stakeholders and team members.
• "Can-Do" attitude and confidence to take on new responsibilities and tasks.
• Open-mindedness and adaptability to consider different perspectives and approaches for success.
• Familiarity with pharmaceutical development processes and GMP-compliant production challenges.

If you meet the requirements and are interested in contributing to a leading pharmaceutical environment, we look forward to receiving your application.

ing project!