QA Project Manager (7085)

Contract

Posted 1 day ago

Recruiter: Alexandra Toma

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world. 

We are currently looking for a:

QA Project Manager for a 1 year contract, extension possible (based on project need) in Basel.

Main responsibilities:

• Lead and support global Technical Research & Development (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.

Qualifications:

• Relevant working/residency permit or Swiss/EU-Citizenship required.
• Bachelor`s or Master`s degree in life sciences or healthcare is required.
• Around 10 years of experience in pharmaceutical quality and medical device/ combination product area experience are mandatory.
• 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 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.
• Fluency in English is mandatory, good knowledge of German would be preferred.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone