Head of Clinical Compliance
NonStop Consulting AG is looking for Head of Clinical Compliance to join our client's Quality Assurance Team.
About our client
Our client is a biopharmaceutical organisation with one of the fastest-growing R&D sites focusing on innovative solutions for cancer treatment. It has a strong development pipeline of products in phases I-III.
About the role
You will lead the Clinical Development Quality Team driving compliance to QMS, ensuring consistent adherence to regulatory requirements and guaranteeing the company's GCP inspection readiness.
- 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 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
- Establish & monitor operational quality objectives of Clinical Development Quality Leads and ensure timely Quality Plan development and execution in line with business/project timelines.
- 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 the selection process
- Provide clinical development quality oversight and contribute /participate during CRO/Vendor Governance meetings
- Build collaborative working relationships with business stakeholders 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 business stakeholders to ensure proper CAPA formulation and follow-up.
- 15 years of experience in an agile biopharmaceutical company, with at least 10 years in Clinical Quality
- 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
- Global business thinking within GCP expert & client area
- Technical skills in view of system / application / software related activities
What to expect in return?
- International, highly dynamic environment with a long-term vision
- Cross-functional collaboration at the forefront of the most advanced scientific developments
- 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
You can contact me via: firstname.lastname@example.org
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About NonStop: We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We're passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting, for more information, to browse all our roles, or to let us know how we can help you.