Quality Lead (m/w/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

Location : Basel, Switzerland