Senior QA Expert for QC Specialist

CTC; Basel; On-site; CHF 120,000 - 160,000; Full time

Job summary

CTC Basel seeks an experienced QA/QC professional to guide GMP-compliant projects for laboratory execution systems. You will work with cross-functional teams to ensure that GMP requirements are met, SOPs are followed, and QC deliverables are achieved.

Ideal candidate has 8+ years in GMP environments, strong cGMP knowledge, interaction with health authorities, and fluent English; German is a plus. The role includes SOP ownership, KPI reporting, and GMP documentation management.

Qualifications

• 8+ years of experience in projects implementing laboratory execution systems in a quality-focused environment.
• Strong background in cGMP regulations (US/European/Japanese Pharmacopoeia).
• Experience interacting with health authorities (FDA, Swissmedic, etc.).
• Fluency in English; German language is a plus.

Responsibilities

• Collaborate with cross-functional teams on growth projects and ensure QA/QC timelines deliverables align with quality objectives.
• Provide guidance and quality oversight for QC activities.
• Support QA for gLIMS implementation and act as QA lead for GMP compliance.

Skills

Cross-functional collaboration

Quality oversight

GMP knowledge

Communication

Attention to detail

Documentation

Problem solving

Agile mindset

Tools

gLIMS

Job description

Main Responsibilities:

• Collaborate closely with cross-functional teams to work on growth projects as per site quality objectives and strategic goals. Ensure that project timelines and deliverables under the responsibility of QA/QC are fulfilled.
• Provides guidance and quality oversight for QC
• Support growth projects and act as primary point of contact in QA for implementation of gLIMS (laboratory execution system)
• Represents the QA support and guidance to the Quality Control (QC) department and ensures that GMP requirements are met and SOPs are followed.
• Review and Approval of GMP relevant documents from quality control, including SOPs with focus on implementation of gLIMS.
• Supervise and execute GMP compliance activities like changes (CRs), document management, non-conformities (DRs)
• Write or revise SOPs in the area of expertise and be the owner of these documents.
• Support QA for QC raw data review, as deemed required
• Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.)
• Management and reporting of KPIs
• Perform/support inspections and audits as required.
• Performs other duties as assigned

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• 8 years + experience in projects in implementation of laboratory execution systems, within a quality-focused environment.
• Strong background in cGMP regulations, including US, European and Japanese Pharmacopoeia.
• Very good knowledge in laboratories/laboratory equipment/software qualification/validation.
• Experience in interaction with health authorities (FDA, Swissmedic, etc.).
• Structured, focused and well-organized working attitude.
• Open-minded for new ideas and suggestions, agile, highly motivated and dynamic drive.
• Pragmatic and solution-orientated mindset.
• Fluent in English, German language is nice to have
• Project management certification would be considered as advantage (Green/Black Belt etc)