QA Project Manager (7085)

About Us

CTC is a specialized search and recruitment partner for the Life Sciences industry, dedicated to connecting talented professionals with meaningful opportunities since 1997. We support our clients in effectively engaging, retaining, and developing exceptional talent.

Company Overview

Our client is a prominent global player in the Pharmaceutical industry, headquartered in Basel, Switzerland. This organization is currently undergoing a transformation in culture and external perception, with a strong focus on novel therapies in Oncology and Ophthalmology. Additionally, they are developing a world-class pipeline in Neuroscience and Dermatology, hosting one of the most robust pipelines of Phase II/III studies globally.

Main Responsibilities

• Lead and support the global Technical Research & Development (TRD) project team, representing TRD QA in global sub-teams, quality board meetings, and project development gate meetings.
• Ensure quality oversight on assigned development projects, providing strong quality guidance, scientific and technical expertise.
• Contribute to project strategies, including contingency planning and risk assessments, ensuring timely project quality deliverables while maintaining compliance with cGMP guidelines and internal procedures.
• Proactively manage interactions of project-related activities among TRD QA and other departments.
• Communicate overall project strategy and critical issues promptly to management and project team members.
• Provide input to contracts and QA agreements with third parties, approving project-specific QA agreement amendments.
• Lead or participate in global and/or cross-functional initiatives.
• Prepare and guide TRD project teams for Mock-PAI and PAI during the submission preparation process.

Qualifications

• Swiss/EU citizenship or a relevant working/residency permit is required.
• A 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.
• Comprehensive understanding of quality standards and policies in Drug Product/Medical Devices manufacturing and control.
• Experience with Health Authority Inspections (especially FDA and EMA), Notified Body inspections, and RegCMC requirements.
• Broad experience in combination product development along with roles in Quality Assurance and/or Quality Control departments.
• Experience in Technical Operations or related equivalent roles is preferred.
• Proven ability to support interdisciplinary teams effectively, especially in TRD or similar environments.
• Strategic thinking, quality awareness, and implementation skills to contribute to matrix teams effectively.
• Computer literacy (e.g., MS Office, document management systems) and a willingness to learn new systems and processes.
• Fluency in English is mandatory, with a good knowledge of German preferred.

Learn More

Are you interested in exploring this opportunity further? CTC is here to provide additional information and insights into the organization.