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

edp personalberatung gmbh; Basel; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

pharmaceutical company in Basel, Switzerland, seeks a Project Manager in Medical Device/QA (m/f/d) for 100% capacity on a temporary basis (01.01.2027 - 31.12.2027, with extension). The role involves leading TRD QA activities, ensuring quality oversight across development projects, and aligning with cGMP guidelines.

Flexible hours and a multicultural team are highlighted. Qualifications include a Bachelor Degree with >10 years in pharma quality or operations, fluent English, and German or French

Qualifikationen

• Bachelor Degree with >10 years in pharma quality or operations.
• Masters Degree with >5 years in pharma quality or operations (desirable).
• Fluent English (oral + written) and good German or French.
• Strong understanding of quality standards in Drug Product/Medical Devices manufacturing.
• Experience with Health Authority inspections (FDA/EMA) and Notified Body inspections.
• Knowledge of RegCMC requirements for NB and Health Authority submissions.
• Broad experience in combination product development and QA/QC.

Aufgaben

• Lead and support global TRD project team and represent TRD QA in global meetings.
• Ensure quality oversight on development projects with guidance and expertise.
• Contribute to project strategy, contingency planning, and risk assessments to meet quality deliverables.
• Manage interactions between TRD QA and other departments.
• Communicate project strategy and critical topics to management and project teams.
• Input to contracts and QA agreements with third parties; approve amendments.
• Lead or participate in global/cross-functional initiatives.
• Prepare and guide TRD project teams for Mock-PAI and PAI during preparation.

Kenntnisse

Bachelor degree

10+ years pharma QA

Masters degree

5+ years pharma QA

English (fluent)

German or French

Quality standards

Health Authority inspections

Notified Body inspections

RegCMC knowledge

Combination product development

Technical Operations

Interdisciplinary teams

Ausbildung

Bachelor Degree

Master Degree

Jobbeschreibung

#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.

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

• 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 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.

Fragen?