Senior Compliance Specialist

hace 2 semanas


Madrid, Madrid, España Novartis Farmacéutica A tiempo completo
Job Summary

In this pivotal role, you will lead and support independent GCP/PV audits, ensuring compliance with Novartis Quality Systems and Standards, Good Clinical Practice (GCP)/Good Pharmacovigilance Practice (GPvP), and current regulations. Your expertise will provide quality guidance and assist in identifying training needs for Global GxP Audit partners.

About the Role
  • Plan, conduct, document, report, and follow up on GCP/PV audits according to Novartis procedures and applicable regulations.
  • Travel up to 60% of the time.
Responsibilities
  1. Lead, support, and report independent GCP/PV audits.
  2. Provide technical guidance and training on audit activities.
  3. Evaluate responses to audit findings and maintain current knowledge of regulations.
  4. Maintain a moderate degree of independence with respect to decision-making and problem-solving.
Requirements
  • Bachelor's degree in natural/biological sciences or equivalent.
  • 5 years' experience in GCP/GPvP/clinical/industry/health authority or equivalent, with 1-2 years of auditing experience preferred.
  • Thorough knowledge of GCP, GPvP, and GxP regulations, guidelines, policies, and procedures.
  • Ability to manage tasks, evaluate compliance issues, and address multiple responsibilities simultaneously.
What We Offer

We offer a competitive salary range: $80,000-$110,000 per annum, depending on qualifications and experience.

$80,000 is an estimated minimum based on average industry rates and considering the level of expertise required. Please note that salaries may vary based on individual circumstances.



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