Are you passionate about upholding high standards of quality in the pharmaceutical industry? Do you thrive in a dynamic, agile environment where your expertise directly contributes to making essential medications accessible to patients worldwide? We are seeking an experienced Quality Manager to join our team in Lancy, Geneva. This role is crucial in ensuring that our products meet rigorous quality and regulatory standards as we expand both in Switzerland and globally.

About Us:
Leman SKL Pharmaceuticals is a private and independent Swiss pharmaceutical company headquartered in Switzerland. With strategically located subsidiaries across Europe, Mexico, and Hong Kong, we operate on a global scale, enhancing our international presence. As a fast-growing company, we pride ourselves on agility, pragmatism, and a dedication to providing valuable products to healthcare professionals and patients. We foster a collaborative, growth-oriented environment where our team members can advance their expertise through hands-on experience and continuous training.

Your Role:
As the Quality Manager, reporting to the Responsible Person, you will be essential in ensuring that our products meet quality and regulatory standards. You will manage quality processes, including the Quality Management System, third-party relationships, and product quality. Your key responsibilities will include:

• QMS Oversight:
  • Maintain and enhance the Quality Management System (QMS) to ensure compliance with GMP/GDP and other relevant regulations.
  • Develop, update, and enforce quality SOPs, and documentation to align with regulatory standards and best practices.
  • Manage change control processes, ensuring all modifications are properly documented, reviewed, and approved.
• Third-Party Qualification:
  • Oversee the qualification process for suppliers, contractors, and other third parties, ensuring compliance with quality standards and regulatory requirements while managing Quality Technical Agreements, review third parties compliance and certification.
  • Coordinate or conduct supplier audits and assessments, monitor performance, and manage quality agreements to uphold product and service quality.
  • Collaborate with external partners to address quality concerns, implement improvements, and ensure alignment with the company’s quality objectives.
• Product Quality Management:
  • Support the Responsible Person for the product release process to ensure that all products meet quality specifications and regulatory standards before commercialization.
  • Investigate or coordinate investigation with CMO on product quality issues, including deviations, non-conformity, and customer complaints, and implement CAPA to prevent recurrence.
  • Oversee product quality monitoring, including annual Product Quality Review (PQR), stability data management and trend analysis, to maintain high product standards.
  • Ensure proper documentation and traceability for all quality-related activities and decisions related to product quality.

Your Profile:

• A minimum of 5 years of experience in quality assurance within the pharmaceutical industry with drugs.
• Background as a Pharmacist, Chemist, or similar, with in-depth knowledge of GMP regulations and Swiss drug registration requirements.
• Ability to work independently on multiple projects with a high level of attention to detail.
• Language proficiency in French and English; German is a plus.

What We Offer:

• Career development: Opportunity to take on Deputy Responsible Person responsibilities and access in-house and external training programs.
• Dynamic work environment: Join a vibrant, growth-focused team in a company that values agility, collaboration, and excellence.
• Benefits: Enjoy 30 days of paid leave per year and the option for partial home office work to support a healthy work-life balance.

Why Join Us Now?
Our company is expanding rapidly, with several new medications set to launch in Switzerland and plans to grow internationally. As Quality Manager, you will play a key role in ensuring the success of our growth while making a real impact on healthcare. If you’re ready to bring your quality assurance expertise to a company that values growth and impact, we would love to hear from you. Apply now to be part of our mission!