Project Manager in Medical Device/QA (m/f/d), 100%

EDP Personalberatung GmbH; Basel; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Extensive training opportunities

Multicultural team

Zusammenfassung

EDP Personalberatung GmbH is assisting a Basel-based pharmaceutical company in recruiting a Project Manager in Medical Device/QA. The role is a temporary 100% position in Basel, with a contract from 01.01.2027 to 31.12.2027 and an option for extension.

You will lead global TRD QA activities, ensure quality oversight on development projects, and drive QA strategy in line with cGMP guidelines. The ideal candidate holds a Bachelor (or higher) with 10+ years in pharma quality or operations, fluent

Qualifikationen

• Bachelor/Master degree with pharma quality or operations experience.
• Experience with regulatory inspections (FDA/EMA) and health authority interactions.
• Knowledge of cGMP and quality standards in drug product/medical devices.
• Proven track record in QA/Quality Assurance and cross-functional teams.

Aufgaben

• Lead and represent TRD QA in global project teams and QA board meetings.
• Ensure quality oversight on development projects per cGMP and TRD QA guidelines.
• Contribute to project strategy, risk assessments and contingency planning.
• Coordinate interactions between TRD QA and other departments.
• Prepare and guide TRD project teams for Mock-PAI and PAI processes.
• Lead cross-functional initiatives.

Kenntnisse

English fluency

German or French

Quality systems knowledge

FDA/EMA inspections

Combination products

Cross-functional collaboration

Ausbildung

Bachelor Degree

Masters Degree

Jobbeschreibung

Project Manager in Medical Device/QA (m/f/d), 100%

Einsatzort:Basel

Art(en) der Anstellung:Temporärstelle, Vollzeit

#MedicalDevice #ProductQA #LeadProjects #Strategies

Our customer, a pharmaceutical company based in Basel, needs reinforcement. For a temporary employment (01.01.2027 – 31.12.2027, with option for extension) we are looking for a motivated and experienced employee.

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 incl. contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables. Ensure that the strategy followed within the assigned projects is in line with TRD QA strategies and goals and in compliance to cGMP guidelines and internal procedures.
• Understand and proactively manage the interactions of project related activities between TRD QA and other departments inside or outside of TRD.
• Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the TRD project leader and/or to any other relevant project team member(s).
• Provide input to contracts and QA agreements with third parties. Approve project-specific QA agreement amendments for assigned projects.
• Lead or participate in global and/or cross-functional initiatives.
• Prepare and guide TRD project teams for Mock-PAI and PAI in the frame of the PAI preparation process and submission preparation.

Your Profile

• Minimum: Bachelor Degree > 10 years’ pharma quality or opeations)
• Desirable: Masters Degree > 5 years’ pharma quality or operations)
• Languages: fluent English required (oral + written), Good skills in German or French
• Fundamental, broad understanding and knowledge of quality standards and policies in Drug Product/Medical Devices (combination products) manufacturing and control.
• Experience with Health Authority Inspections (FDA and EMA in particular), Notified Body inspections and knowledge of RegCMC requirements for NB, Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
• Broad experience in combination product development as well as in Quality Assurance and/or Quality Control departments.
• Experience in Technical Operations or equivalent experience.
• Proven track record in successfully supporting interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TRD or equivalent experience.
• Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.

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

Questions?

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Abteilungen:Life Sciences