Global Quality Regulatory Compliance Specialist

hace 1 semana


Xico, México Novartis A tiempo completo

About the Role

Novartis is seeking a seasoned Global Quality Regulatory Compliance Specialist to lead, support, and report independent GCP/PV audits. The ideal candidate will have 7+ years of experience in GCP/PV/Pharmaceutical Industry/Health Authority or equivalent, with 3 years of GCP/PV auditing experience, preferably 5 years. Fluency in English at an operational and functional level is required.

Main Responsibilities:

  • Support the strategic development of an effective global risk-based audit strategy and programme.
  • Lead, plan, conduct, document, and follow-up on global quality regulatory compliance audits and assessments of GCP/GPvP.
  • Assess the adequacy of responses (CAPA plans) to audit findings.
  • Identify and communicate quality and regulatory compliance issues to Quality Management.
  • Execute the risk-based Unified Quality Audit Plan (UQAP).

Requirements:

  • Advanced degree desirable.
  • Excellent verbal and written communication, organizational, and interpersonal skills.
  • Extensive knowledge of applicable GCP, PV, and GxP regulations, guidelines, policies, and procedures.
  • Ability to lead audit teams and operate successfully in various team capacities.

Benefits: We offer a competitive salary range of $120,000 - $180,000 per annum, depending on experience, as well as excellent benefits and opportunities for career growth.



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