QC Senior Project Expert Team Lead

Overview

Our client is looking for an experienced QC Team Lead to join a successful CDMO branch, located in Basel, Switzerland.

This role is open to EU citizens willing to relocate to Switzerland (relocation assistance is provided).

Fluency in English language is essential for this role.

Key responsibilities

• Lead, manage and develop a team of experienced Project Leaders.
• Provide successful and compliant guidance and support to project leaders on general and specific aspects of quality and analytical development challenges
• Take responsibility and accountability as business processes owner and procedures owner including continuous development and improvement of concepts as required
• Accountable for the successful definition and implementation of late phase QC development standard stages of work including definition of related capacity planning embedded into overall development concept
• Manage quality events as required, e.g. deviations, CAPA, change requests
• Network and liaise effectively with partner units and relevant stakeholders within the network to contribute to the department`s success and positive perception.
• Ensure effective use of resources (time, personnel, equipment, etc.), cGMP and EHS (environment, health and safety) guidelines are followed and continuously evolved as required
• Lead initiatives to support the growth of Development QC on GMP compliant development of new entities, e.g. bioconjugates, viral vectors and small molecules (liquids).

Minimum Required Qualifications/Skills

• PhD or MSc in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences or related field
• Extensive working experience in Analytics or Quality Control of pharmaceuticals is a must, preferably for Biologics and under cGMP regulations
• Substantial experience in late phase to launch development activities is a must
• Experience with development QC of drug product bioconjugates and viral vectors in addition to antibodies/proteins is beneficial
• Proven leadership experience (matrix and leading leaders) including proven track record in leading organizational transformations
• Demonstrated skills to persuade key stakeholders both cross-functional and cross-site
• Fluent in English is a must

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