Job Title: Quality Lead / Qualified Person
Location: Neuchâtel, Switzerland (On-site mainly)
Employment Type: Full-time, permanent position
Languages Required: English (C1), French (C1), German (C1)
About the Role:
Cpl Life Sciences is collaborating with a growing Swiss CRO that are looking for an experienced and highly motivated Quality Lead to take full responsibility for compliance with Swiss GDP regulations.
The role is essential for ensuring compliant batch release, maintaining the quality management system (QMS), and overseeing the compliant distribution of pharmaceutical products in Switzerland.
Key Responsibilities:
* Serve as “Qualified Person” / “Responsable Technique” in accordance with Swiss law and regulatory requirements.
* Oversee and approve batch releases for distribution in Switzerland.
* Maintain and continuously improve the QMS, ensuring full compliance with Good Distribution Practice (GDP) and other applicable standards.
* Manage and update SOPs to reflect current best practices and regulatory expectations, in accordance with company distributed products.
* Establish, review, and manage quality and technical agreements (QTA) with providers and suppliers.
* Lead the preparation, coordination, and management of inspections by regulatory authorities, when necessary.
* Oversee CAPA management and ensure timely execution and documentation of follow-up actions.
* Support audits (internal and external), deviation handling, and change control processes.
* Collaborate cross-functionally and act as a key point of contact for quality matters with internal teams and partners.
* When and if needed: maintain and develop QMS system linked to clinical trials activities to ensure GCP compliance (e.g. SOPs review and development).
Requirements:
* Degree in Pharmacy, Life Sciences, or a related field, and eligibility to act as a Qualified Person (Responsable Technique) under Swiss law.
* At least 5 years of experience in quality assurance within the pharmaceutical industry, with a strong focus on GDP and/or GMP.
* Proven experience with batch release, QMS management, quality audits, and regulatory inspections.
* In-depth knowledge of Swissmedic requirements, EU GDP/GMP guidelines, and international quality standards.
* Strong interpersonal and communication skills with the ability to build collaborative relationships.
* Proactive, detail-oriented, and able to manage multiple priorities in a regulated environment.
You must be based in Switzerland and have the full right to work.
For more information, please reach out to me at lucy.kirkaldy@cpl.com
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