QA Project Manager / QA Project Manageress

About CTC

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

About the Client

Our client is a leading global player in the Pharmaceutical industry, headquartered in Basel, Switzerland. They are undergoing a transformation in culture and external perception. The organization focuses on novel therapies in Oncology and Ophthalmology and is currently developing a world-leading pipeline in Neuroscience and Dermatology, featuring one of the strongest pipelines of Phase II/III studies globally.

Position: QA Project Manager

This position offers a 1-year contract, with the possibility of extension based on project needs, located in Basel.

Main Responsibilities

• Lead and support the global Technical Research & Development (TRD) project team, representing TRD QA globally in TRD sub-teams and at global quality board meetings and project development gate meetings.
• Ensure quality oversight on assigned development projects by providing strong quality guidance, scientific, and technical expertise.
• Contribute to the strategy of assigned projects, including contingency planning and risk assessments, ensuring timely achievement of project quality deliverables.
• Ensure that the strategy followed within assigned projects aligns with TRD QA strategies and goals and complies with cGMP guidelines and internal procedures.
• Understand and proactively manage interactions related to project activities between TRD QA and other departments, both within and outside of TRD.
• Communicate overall project strategy, key issues, and other critical topics in a timely manner to appropriate management levels, the TRD project leader, and other relevant project team members.
• Provide input on 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 framework 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.
• Approximately 10 years of experience in pharmaceutical quality and medical device/combination product areas are mandatory.
• 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 and Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
• Extensive experience in combination product development, as well as Quality Assurance and/or Quality Control departments.
• Preferred: Experience in Technical Operations or equivalent experience from an external company.
• Proven track record in successfully supporting interdisciplinary teams, such as scientists working on technical or methodological projects in TRD or equivalent experience from an external company or other line function.
• Ability to contribute strategically to matrix teams with necessary 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; proficiency in German is preferred.

Application Process

Apply online using the form below. Only applications matching the job profile will be considered. Thank you for your interest!