Quality Lead (m/f/d), 100%

TieTalent; Basel; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A leading Swiss pharmaceutical company is seeking a Quality Lead to ensure quality oversight on development projects and provide scientific expertise. The role involves leading interdisciplinary teams, complying with regulatory standards, and contributing to project strategies. Candidates must have robust experience in pharmaceutical quality and a degree in a relevant field.

Leistungen

Flexible working hours

Extensive training opportunities

Motivated multicultural team

Qualifikationen

• Broad understanding of quality standards in Drug Substance/Drug Product/Medical Devices.
• Experience with Health Authority Inspections (FDA, EMA).
• 5-10 years of experience in drug development and QA/QC.

Aufgaben

• Lead and support the global TRD project team.
• Ensure quality oversight on assigned development projects.
• Proactively communicate project strategies and issues.

Kenntnisse

Leadership

Quality standards

Regulatory knowledge

Communication

MS Office

Ausbildung

Bachelor's or Master's degree in pharma quality or operations

Jobbeschreibung

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About

Our customer, a pharmaceutical company based in Basel, needs reinforcement. For a temporary employment (01.09.2025 – 30.09.2026), we are looking for a
Quality Lead (m/f/d), 100%

Benefits

• An internationally operating, innovative Swiss pharmaceutical company, a leader in its field
• Flexible working hours and extensive training opportunities
• A motivated multicultural team and environment

Your Main Responsibilities

• Lead and support global TRD project team, and represent TRD QA globally in TRD sub-teams, as well as at global quality board meetings and project development gate meetings.
• Ensure quality oversight on the assigned development projects with strong quality guidance, scientific and technical expertise.
• Contribute to the strategy of assigned projects including contingency planning and risk assessments to ensure timely achievement of project quality deliverables. Ensure alignment with TRD QA strategies and compliance with cGMP guidelines and internal procedures.
• Understand and proactively manage interactions of project-related activities between TRD QA and other departments.
• Proactively communicate overall project strategy, key issues, and critical topics to management, TRD project leader, and relevant team members.
• Represent TRD QA in Due Diligence teams, provide quality assessment of potential in-licensing products, and support follow-up activities.

Your Profile

• Broad understanding of quality standards in Drug Substance/Drug Product/Medical Devices manufacturing and control.
• Experience with Health Authority Inspections (FDA, EMA) and knowledge of RegCMC requirements for submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
• Experience in technical drug development and QA/QC departments, with leadership experience in interdisciplinary teams.
• Proficiency in MS Office and document management systems, with willingness to learn new systems.
• Bachelor's or Master's degree in pharma quality or operations, with 5-10 years of experience.
• Fluent in English; knowledge of local language is a plus.

Location: Basel, Switzerland

Job Type: Temporary, Mid-Senior Level, QA

Industries: Pharmaceuticals

Note: This job posting is active and not expired.