QA Project Manager

QA Project Manager #

(m/f/d)

Freelance/temporary employment for a project

Basel

Start date: asap

Reference number: 892961/1

Responsibilities ###

• Lead and support global RnD project team, and represent QA globally in RnD 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 RnD QA strategies and goals and in compliance to cGMP guidelines and internal procedures
• Understand and proactively manage the interactions of project related activities between RnD QA and other departments inside or outside of RnD
• Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the RnD 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

Profile ###

• Bachelor
• 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 from external company is preferred
• Proven track record in successfully supporting interdisciplinary teams, e.g. scientists working on technical or methodological projects, in RnD 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 site (local) language desired (oral)

Benefits ###

• Leadership role
• International work environment