QA Lead - Medical Devices & Packaging Development

For our client based in Basel (CH) we're urgently looking for a QA Lead – Medical Devices & Packaging Develop men
t with following details:

• Duration: 01.08.
• Gross Rate Range (given by client): max. 83,50 chf/h gross. Typical monthly salary, e.g. 73chf/h gross
  * 160h -> 11.680 chf gross/month

Lead and support complex projects and quality initiatives. Drive small sub team as part of a matrix organization. Expertise in medical devices. Lead, guide and support global GDPD (Global Device and Packaging Development, Technical Research and Development) project teams in all quality-relevant topics, questions, and issues. Develop project strategies in alignment with GDPD considering all relevant cross-functional aspects to ensure the quality of deliverables within the project.

QA DDS (QA Drug Delivery Systems) representative at expert panel;
Lead and support QA aspects of new technology projects.

• Lead and support global GDPD project teams, and represent QA DDS globally in project 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 QA DDS strategies and goals and in compliance to external and internal medical devices requirements and processes.
• Understand and proactively manage the interactions of project related activities between QA DDS and other departments inside or outside of QA DDS.
• Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the GDPD project leader and/or to any other relevant project team member(s).
• Provide input to contracts and QA agreements with 3rd parties. Approve project-specific QA agreement amendments for assigned projects.
• Lead or participate in global and/or cross-functional initiatives.
• Collaborate with GDPD, as part of device project teams, providing quality oversight and acting as QA approver for technical documentation.
• Support impact assessments and related actions associated with changes to the design and manufacturing of medical devices.
• Contribute to the authoring and maintenance of QMS documentation, such as SOPs, WPs, FRMs, and ATTs.
• Support teams in the preparation and hosting of Notified Body inspections.
• Act as QA approver for 1
  
  QEM records (Trackwise system), including deviations and OOX records.
• Support impact assessments for new regulations and standards related to medical devices, including the definition and tracking of resulting actions.
• Help manage project trackers and prepare materials for governance and management forums

• Education:
  
  Bachelor (> 10 years’ pharma quality or operations), Masters (> 5 years’ pharma quality or operations)
• Languages:
  
  Fluent English required (oral & written), Good skills in German desired (oral)
• Fundamental, broad understanding and knowledge of quality standards and policies in Medical Devices manufacturing and control.
• Experience with Notified Body Inspections.
• Broad experience in device development as well as in Quality Assurance and/or Quality Control departments.
• Proven track record in successfully leading interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TRD or equivalent experience from external company or other line function.
• Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.
• Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes.