Quality Lead (m/f/d)

Tasks:

• Lead quality oversight of global TRD development projects, ensuring compliance with cGMP, 21 CFR 820, CFR Part 4, ISO 13485, and internal quality procedures.

• Provide strong quality guidance and scientific/technical expertise for assigned projects.

• Contribute to the development of project quality strategies, including risk assessments, contingency planning, and alignment with TRD QA goals.

• Represent TRD QA globally in TRD sub-teams, global quality boards, and project development gate meetings.

• Act as QA representative at expert panels for new technology projects and complex due diligence activities.

• Proactively communicate project strategy, quality issues, and critical topics to senior management, TRD project leaders, and relevant stakeholders.

• Lead PAI (Pre-Approval Inspection) and submission readiness activities, including Mock-PAIs and inspection site preparation.

• Support and participate in audits and regulatory inspections.

• Ensure QA oversight for commercial distributed SaMD projects.

• Provide QA support for medical devices, drug-device combination products, and SaMD, ensuring integration with BD&L projects and due diligence requirements.

• Review and approve project-specific QA agreements and amendments with third parties.

• Participate in or lead interface meetings with Device Development line units to address and improve GMP/QMS topics.

• Lead or participate in global and cross-functional quality initiatives.

• Provide QA input on contracts and agreements with external partners.

• Contribute to continuous improvement of quality systems and processes.

• Coach and mentor QA functional experts.

• Participate in recruiting and onboarding QA team members

Qualification:

• Bachelor’s degree with 10+ years of experience in medical device or combination product quality OR

• Master’s degree with 5+ years of experience in medical device or combination product quality

• Fluent English (oral and written) required

• Good skills in local site language (German preferred)

• Proven expertise in quality leadership for medical devices, combination products, and SaMD

• In-depth knowledge of 21 CFR 820, CFR Part 4, ISO 13485, and GMP guidelines.

• Experience with due diligence, BD&L project integration, and quality support in audits and inspections.

• Experience with Health Authority inspections (FDA, EMA) and regulatory submission preparation.

• Broad knowledge of technical drug development, QA, and/or QC functions.

• Ability to lead complex projects and interdisciplinary teams within a matrix organization.

• Strong communication, risk assessment, and strategic thinking skills.

• Computer literacy (e.g., MS Office, document management systems) and willingness to learn new systems.

Requirements:

Start : 01.09.2025

Location : Basel, Switzerland