Limula SA is a Life Science start-up based in Lausanne, Switzerland. Our company was established with the mission to help bring the most personalised cancer treatments to the patients in need, at reasonable cost, wherever they are. To achieve this goal, our multidisciplinary team provides a unique cell processing solution that enables the production of highly personalised therapies at scale, through automation.
We have the ambition to grow our team with a proactive approach to excellence and diversity, adding more passion and know-how with every individual we bring on board.
QUALITY ASSURANCE MANAGER (F/M, 40-80%)
LOCATION: BIOPÔLE, EPALINGES, SWITZERLAND
START DATE: 1 SEPTEMBER 2023 OR LATER
You want to discover what it is like to work in a fast-paced, mission-driven start-up environment? You have the ambition to contribute to an ambitious project while learning new skills? You are flexible and dedicated, ready to tackle challenges and broaden your skill set? This role is for you!
To support Limula in establishing its Quality Standards to begin treating patients with our products, you will lead the development and implementation of our quality management system (QMS) and ensure compliance with regulatory requirements. As Quality Manager you will be responsible for all aspects of quality control and quality assurance. Due to the variety of cell therapy applications our technology can support, the position includes a wide range of tasks and responsibilities. In addition, the small size of the company and the flat hierarchies allow for continuous and non-bureaucratic improvements for you to shape our quality strategy, reporting directly to the COO.
- Take overall responsibility for quality policies, standards, procedures, and guidelines.
- Develop, implement, and continuously improve the company’s Quality Management System (QMS) covering the following:
- Internal activities (R&D, Industrialisation, Documentation).
- External activities (Manufacturing, Sales, Market monitoring).
- Develop and implement supplier qualification and evaluation processes.
- Ensure that all suppliers are meeting the company's quality requirements.
- Collect quality and regulatory requirements from customers, ensure our products meet them.
- Manage the non-conformance and corrective and preventive action (CAPA) processes.
- Implement and manage the document control system.
- Interface with regulatory agencies and auditors during inspections and audits.
- Conduct internal audits to ensure compliance with regulatory requirements and company policies.
- Manage the calibration and maintenance of all equipment.
- Ensure that all products are released only after meeting the company's quality standards.
- Champion a Quality culture in the company, train other employees on procedures and guidelines.
- Degree in natural sciences or engineering.
- 3-5 years of quality management experience in the life science tools or medical device industry.
- Experience in implementing and managing a QMS and risk management approaches.
- Good knowledge of ATMP/GMP regulations, ISO standards, and industry best practices.
- In-depth knowledge of ISO 13485:2016 and 21 CFR 820 would be a plus.
- Experience with interacting with regulatory bodies, including FDA and EMA.
- Excellent verbal and written communication skills in English.
- Attention to details, analytical and structured work, problem-solving skills.
- Sustained capacity to meet deadlines.
- "Roll up your sleeves" attitude, ability to work in a multidisciplinary, multinational team.
- Company mission that aims to impact the lives of patients with life threatening conditions.
- Innovative and multidisciplinary project, at the interface between engineering and biology.
- An opportunity to work in the CGT industry, one of the most exciting fast growing medical fields.
- Fast-paced, highly stimulating environment with a collaborative atmosphere.
Unique opportunity to join a company at an early stage, with avenues for career development.
- Competitive salary, with additional advantages and incentives including a fully-funded pension.
- Respectful and equal opportunity work environment, in a world-class location.
Limula strives to build a diverse team, and particularly encourages women to apply.
Submit your resume and a motivation letter for this position, in a single pdf file by 1 August 2023. Interviews will be scheduled on a rolling basis, so don’t delay!
To apply, or to request more information, please contact:
Thomas Eaton, COO
Resumes submitted by recruiters or staffing agencies in advance of an executed agreement with Limula SA will be considered unsolicited and the company will not be responsible for any related fees.