Quality Assurance Manager

vor 2 Wochen

Lausanne, Schweiz Limula Vollzeit

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: Biopole, Epalinges, Lausanne, 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_

**_ Position Summary_**

**_ Responsibilities_**
- _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._

**Requirements**:

- _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._

**Benefits**
- _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_

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