Quality Project Manager

For our well-known client in Solothurn we're looking for a Quality Project Manager for a 7 months project.

Role: Quality Project Manager
Location: Zuchwil (Solothurn)
Duration: 29.05.2017 - 31.12.2017
Workload: 100%

Role Description:
. The Quality Manager will lead and support all system, process, procedures for End to End multi-variant readiness across all systems, BU and worldwide sites.
. Liaise with all key stakeholders in building and executing on the Multi-variant readiness.
. Work directly with the Plant Quality Managers at the sites in the company's network to prepare and execute variant introduction.

Quality work stream key responsibilities:
. Support process and technology mapping related.
. Deliver mitigated risk assessment across business (PFMEA).
. Implement mitigations and assess control of the solutions.
. Organize and conduct system validations across business.
. Refine compliant distribution requirements.
. Change/Update procedures as required with other work streams.
. Prepare and execute system testing plan.
. Understand dependencies across work stream for change impact.
. Identify critical path and risks to project timeline.
. Issue status reports and effectively communicate to upper management.
. Work closely to support all testing.
. Update the full-scale End to End Business quality related flow and associated communication documents.
. Quantify the resources needed to achieve work stream project goals.
. Negotiate with other managers for the acquisition of required personnel from within the company to assess, prepare and perform all updates.

Core Team Responsibilities:
. Develop, confirm, commit & deliver FPOs
. Develop and agree to their own Kry Deliverables
. Identify their required resources/Extend team members
. Rigorous participation in core team meetings
. Communicate Key Deliverables status/issues to core team
. Support other Core team members
. Explain communication plan to extended team members and functional management
. Stay with project team until the project close-out

Qualifications:
* University/Bachelor's Degree or Equivalent in a Life Science, Engineering, or Physical Science discipline.
* Integrity around estimations and communications

Knowledge:
. 5+ years of relevant experience.
. Fluent working in English. German or Italian are a plus.
. Project leadership experience.
. Previous proven Quality experience on large scale enterprises on medical devices requirements and compliance knowledge
. GMP, GDP, ISO 13485, CFR 820
. FMEA/Risk approach/Mapping experience
. Operational Equipment qualification and/or CSV validation experience
. Excellent cultural awareness.
. Supply chain experience in medical device or pharmaceutical industry

Skills:
. Influencing and managing others.
. Strong organization skills.
. Can drive continuous process improvements
. Having the ability to work at both a macro and micro level as required.
. Ability to translate complex situations into simple working solutions
. Proactive leadership approach with demonstrated skills in delivering major programs on time and within budget
. Proficient user of MS Office, Excel, Word, Powerpoint, MS Project