Quality Assurance Specialist: Clinical Process Excellence
hace 2 semanas
Job Description Summary
As the primary quality contact for Business Process Owners (BPOs) in Development, you will be responsible for ensuring seamless quality oversight of clinical processes. Your mission is to uphold the highest standards of compliance with Health Authorities' requirements and internal benchmarks.
Key Responsibilities
• Actively drive a culture of Quality and successfully embed a Quality mindset across Development 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.
• Monitor and evaluate changes in regulations, best practices, and internal process working groups, and promptly initiate changes to clinical processes as applicable.
• Guide Quality System Owners (QSOs) and BPOs in the development of a robust strategy for clinical process changes, considering interdependencies and guide respective risk business owners in all aspects of risk management.
About this role:
In this dynamic role, you will forge powerful partnerships within CQA and RDQ, providing strategic and operational QA/GxP expertise. You will be the champion of a quality mindset, driving alignment with the broader goals of RDQ and Development. Your leadership will inspire a culture of excellence, ensuring that every step taken is a stride towards unparalleled quality and success.
Working model:
All locations have a hybrid working model (12 days per month in the office).
Location:
Primary Location: Barcelona or Madrid, Spain. Alternate Location(s): London, England / Dublin, Ireland.
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