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Quality Lead (M/F/D)
Tasks:
Lead Quality Oversight of global TRD development projects, ensuring compliance with cGMP and internal quality procedures across all deliverables.
Develop and Implement Project Quality Strategies, including risk assessments and contingency planning, aligned with TRD QA objectives and cross-functional inputs.
Represent TRD QA in Global Teams, including TRD sub-teams, global quality boards, development gate meetings, and due diligence evaluations.
Guide PAI and Submission Readiness Activities, including leading Mock-PAIs and ensuring inspection site preparedness for Health Authority inspections.
Support QA for Medical Devices, SaMD, and Drug-Device Combinations, ensuring compliance with 21 CFR 820 / CFR Part 4, ISO 13485, and integration with BD&L projects.
Provide QA Input on Contracts and Agreements, including quality terms with third parties and project-specific QA amendments.
Contribute to QA Aspects of New Technologies and lead or support cross-functional innovation and quality improvement initiatives.
Ensure Effective QA Communication and Stakeholder Alignment, proactively addressing key quality issues, project strategy, and timelines with leadership and teams.
Support and Participate in Audits/Inspections, offering QA guidance during internal and external audits as well as regulatory inspections.
Coach, Mentor, and Recruit QA Experts, fostering technical expertise and supporting the growth and alignment of QA personnel within TRD.
Qualification:
Bachelor (10 years’ pharma quality or operations) or Masters (5 years’ pharma quality or operations)
Fluent English required (oral & written)
Good skills in site (local) language German desired (oral)
Fundamental, broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/Medical Devices manufacturing and control
Experience with Health Authority Inspections (FDA and EMA in particular), and knowledge of RegCMC requirements for Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs)
Broad experience in technical drug development as well as in Quality Assurance and/or Quality Control departments
Experience in Technical Operations or equivalent experience from external company is preferred
Proven track record in successfully leading interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TRD or equivalent experience from external company or other line function
Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills
Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes
Requirements:
Start: 01.09.2025
Duration: 12 months
Capacity: 5 days per week (3 days on-site; 2 days remote)
Location: Basel, Switzerland
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