Director QA/QC

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz Proclinical Vollzeit

Proclinical is seeking a dedicated and experienced Director for Quality Assurance/Quality Control. The successful candidate will be responsible for establishing, implementing and maintaining a quality management system for a preclinical stage biotechnology company. This role offers a unique opportunity to contribute to a fast-growing enterprise and work within an experienced, vibrant, and agile team.

Responsibilities:

Develop and implement a comprehensive quality management system that aligns with regulatory requirements and industry standards.Contribute to the development and maintenance of a suitable quality strategy and standards.Create and maintain essential quality documents and procedures, ensuring compliance.Review and approve GMP documents and GMP quality events.Prepare for batch release by external QP(s) and act as QA representative in development teams.Support vendor qualification including planning and execution of vendor audits.Establish plans for Quality Control and audit policies of vendors.Provide guidance for the supply chain and release processes of clinical phase I products.Lead the development and implementation of training programs for quality management system requirements.Conduct internal and external audits to ensure compliance with regulations, standards and SOPs.Collaborate with senior management to identify and implement process improvements and quality initiatives. Key Skills and Requirements:Proven experience in (GMP) Quality Assurance in the Biopharmaceutical Industry.Deep understanding of GxP principles and essentials for an early-stage QM system.Ability to develop practical approaches for quality assurance in a development-focused start-up environment.Experience with internal and/or external audits.Team player spirit and a resourceful and fast learning mindset.Good communication and interpersonal skills.Knowledge of electronic document or quality management system is a plus. Interested or know someone who might be? Reach out to Antoine Mortiaux using the following:

Apply Now: If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page. Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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