Global Quality Regulatory Compliance Specialist
hace 1 semana
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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