Clinical Process Excellence Leader
hace 6 días
Overview
About Novartis
Novartis is a leading healthcare company that has been committed to finding innovative solutions for some of the world's most complex medical challenges. Our mission is to discover new ways to improve and extend people's lives.
Career Opportunity
We are seeking an experienced Clinical Process Excellence Leader to join our team in Barcelona or Madrid, Spain. As a key member of our Development department, you will play a vital role in ensuring the highest standards of compliance with Health Authorities' requirements and internal benchmarks.
About the Role
This dynamic position offers 2 available positions, with a hybrid working model (12 days per month in the office). You will work closely with Business Process Owners (BPOs) and regulatory representatives to provide comprehensive guidance on clinical process changes, considering interdependencies and risk management.
Key Responsibilities
- Actively drive a culture of Quality by forging strong business partnerships, positively impacting business deliverables, and effectively implementing the strategy, mission, and purpose of RDQ.
- Collaborate with BPOs to conduct regulatory requirements gap assessments and implement necessary actions to address any identified gaps.
- Maintain close collaboration with QSOs and BPOs in developing robust strategies for clinical process changes, considering interdependencies and guide respective risk business owners in all aspects of risk management.
- Collaborate closely with Head GCP Inspection Management and GCP Inspection Project Managers when a GCP Health Authority Inspection is announced, promptly identifying potential risk areas that may impact the process.
- Ensure seamless quality oversight of clinical processes, upholding the highest standards of compliance with Health Authorities' requirements and internal benchmarks.
Requirements and Qualifications
- A proven track record in quality assurance, regulatory compliance, and clinical process excellence.
- Strong leadership skills, with experience in driving cultural change and embedding a quality mindset.
- Excellent communication and interpersonal skills, with ability to build strong relationships with cross-functional teams.
- Knowledge of relevant regulations, guidelines, and industry standards.
What We Offer
- A competitive salary of €70,000 - €90,000 per year, depending on experience.
- A comprehensive benefits package, including health insurance, pension plan, and generous leave entitlement.
- Ongoing training and development opportunities to support your career growth.
- A collaborative and dynamic work environment, with a focus on teamwork and innovation.
How to Apply
Please submit your application, including your CV and a cover letter outlining your experience and qualifications for this role.
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