Clinical Development Quality Team Lead

vor 2 Wochen

Lausanne, Schweiz Debiopharm Vollzeit

Description

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

Clinical Development Quality Team Lead, (Ass) Director

The Clinical Development Quality Team Lead will lead the Clinical Development Quality Team driving compliance to the DPIs Quality Management System (QMS), ensuring consistent adherence to regulatory requirements and guaranteeing the company is Good Clinical Practice (GCP) inspection ready at all times.

**Your responsibilities will be but not limited to**:
Act as a strategic driver to evaluate, optimize and implement the pro-active, fit-for-purpose and risk-based Clinical Quality Strategy ensuring compliance during the day-to-day clinical drug development activities
Drive the quality culture and create quality awareness throughout the clinical development organization
Drive effective planning/project management of Clinical Development Quality activities across DPI portfolio.
Lead/manage a team of Clinical Development Quality Leads ensuring proper risk-based quality support at a project level.
Allocate dedicated compliance resources to adequately support the respective Clinical Development activities.
Coach and lead Quality representatives and Business stakeholders by providing leadership, expert advice, support and management for translating the Quality strategy into operations
Contribute to preferred CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process.
Provide clinical development quality oversight and contribute / participate during CRO/Vendor Governance meetings.
Build collaborative working relationships with business stakeholders (including senior leaders) and ensure adequate communication within the compound-specific teams and cross-functional Quality peers.
Drive and ensure continuous alignment on the clinical development quality ways of working across the different projects/clinical trials through engaging with key stakeholders and functional teams.
Oversee and/or contribute to compound-specific Regulatory Authority Inspections / Due Diligence Activities.
Ensure adequate Audit / CAPA support of Clinical Development Quality Leads, by assisting the DPI business stakeholders to ensure proper CAPA formulation and follow-up.
Might act as Clinical Development Quality Lead of a specific project or as back-up if required.

**Requirements**:
At least 15 years’ experience in an agile, mid-size biopharmaceutical company, with at least 10 years in Clinical Quality.
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 Clinical 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)
Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities. Ability to make timely and appropriate decisions as related to the GCP expert and client area
Capability to quickly analyze problems, communication options and take appropriate action for resolution
Demonstrates consistent judgement under usual business conditions. Involves others in decision-making processes as appropriate
Effective cross-functional and cross-cultural skills
Global business thinking within GCP expert & client area
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 em

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