Quality Lead – R&D & Technology Development (m/f/d), 100%

#GDPD #QA #DrugDeliverySystem #Development #Research #YourNewJob

Our customer, a pharmaceutical company based in Basel, needs reinforcement. For a temporary employment (on-site) (asap – 30.06.2027, with option for extension) we are looking for a experienced Quality Lead.

Quality Lead – R&D & Technology Development (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 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.

Your Profile

• MSc, BSc in Pharma quality or operations, or other relevant discipline
• 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.
• Fluent English required (oral & written). Good skills in German desired (oral).

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