Qms Team Lead,

vor 3 Wochen

Lausanne, Schweiz Debiopharm Vollzeit

**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally._
- At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target._

For our Quality Assurance organization based at our Headquarters in Lausanne, we are looking for a

**Quality Management Systems (QMS) Team Lead, (Ass) Director**

The Quality Management Team Lead will be responsible for the overall governance of the DPI Quality Management System from a Process and Training perspective to ensure that a robust, fit-for-purpose, sustainable and effective quality management system is in place to drive day-to-day GxP development activities.

**Your responsibilities will be but not limited to**:

- Act as a strategic driver to build and implement a sustainable transversal QMS Procedural Document (ProcDoc) / Training Framework driving the day-to-day GxP development activities
- Evaluate operations from a strategic level to ensure that the QMS consistently meet quality and regulatory requirements from a Procedural Document and Training perspective.
- Take a lead role in the transversal QMS Procedural Document & Training Governance ensuring harmonization, efficiencies and simplification where appropriate.
- In collaboration with Business stakeholders (incl. senior leaders / process owners), develop and implement streamlined processes / procedural documents compliant with regulatory, industry, and internal quality standards.
- Drive and ensure continuous alignment with QMS ProcDoc / Training principles and ways of working across the different functional areas through engaging with key stakeholders, functional teams, and Process Owners.
- Provide oversight for the development and maintenance of the Quality Management System and related electronic systems, processes and procedures that ensure compliance with internal and external standards.
- Coach and lead Business stakeholders and Quality representatives by providing leadership, expert advice, support and management for translating QMS ProcDoc & Training strategy into operations.
- Foster a change management culture to facilitate adoption and usage of new ways of working. Act as a “Change Agent” to drive the culture of process improvement throughout the organization.
- Management and reporting of quality key performance indicators related Procedural Document and Training Management

**Requirements**:

- At least 15 years ‘experience in Pharma Industry, with at least 10 years in QA and/or QMS roles
- Master’s degree in science
- Expertise in Quality Management Systems in a regulated, agile, mid-size biopharmaceutical company; in transversal GXP (preferably GCP) Quality Management System and related operations
- Master’s degree in Science
- Ability to be a strategical thinker and be a driver to bring efficiencies and simplifications in daily activities
- Having demonstrated the ability to drive significant changes in a Quality Management organization
- Experience in strategic partnering with senior leaders and quality representatives
- A comprehensive working knowledge of data integrity and risk management (risk assessment and risk mitigation)
- A good and thorough understanding of current regulatory requirements.
- Ability to interpret current regulations and requirements is essential
- Excellent verbal and written communication and interpersonal skills
- Excellent presentation skills and ability to present content in front of senior management
- Rigor, flexibility, adaptability, and organization
- Pragmatism focused on efficiency and continuous improvement

**Benefits**

**Debiopharm offers employees**:

- International, highly dynamic environment with a long term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
- Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees

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