Senior Good Clinical Practices

******BR**Senior Good Clinical Practices -Pharmacovigilance Auditor**:Mexico**About the role**LI:#Hybrid roleAbout the role:Lead, support and report independent GCP/PV audits according to the NVS Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and documents.Review and approve corrective action plans in support of the audit observationsMain Responsibilities:- Support the strategic development of an effective global risk-based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan.- Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and documents.Perform activities with a high degree of independence.- Assess the adequacy of responses (CAPA plans) to audit findings in agreement with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP)- Identify and communicate quality and regulatory compliance issues to Quality Management through appropriate channels as well as recommend remediation.- Execution of the risk based Unified Quality Audit Plan (UQAP).- Accuracy of findings and completion of audits and finalization of audit reports within established timelines, procedures and agreed upon standards/Key Performance Indicators (critical metrics).Effective analysis of audit metrics and causes of non-compliance.- Timely customer concern through accurate channels of issues and findings that impact NVS Good Clinical Practice/Pharmacovigilance and risk benefit evaluation capabilities.Timely, complete and accurate communication, consultation and support to business partners.- Effective facilitation and follow-up of HA inspections, as assigned.Effective collaboration on quality/compliance remediation and improvement initiatives; timely completion of projects.Timely review and feedback on policies, procedures and associated documents.Lead compliance investigations and initiatives passionate about inspection readiness and quality, process and compliance improvement as requested.**Commitment to Diversity & Inclusion**:- Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve._**Role Requirements**Education(minimum/desirable): - Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience)- Advance degree desirableLanguages:**Experience**:- English fluency at operational and functional level (as first or second language; second language a plus)- 7+ years of GCP/PV/PharmaceuticalIndustry/Health Authority experience or equivalent;- 3 years of GCP/PV auditing experience; 5 years preferred; experienced in both GCP and PV auditing is ideal;- Willingness to travel approximately 60% of the time.- Ability to independently manage and objectively evaluate complex compliance issues with mínimal supervision;- Ability to address a variety of tasks within the same timeframe while maintaining oversight; ability to maintain a high degree of independence with respect to decision making and problem solving;- Experience with Health Authority inspections and interaction;- Excellent quality and compliance leadership and facilitation skills;- Excellent verbal and written communication, organizational and interpersonal skills;- Excellent computer skills, including Excel, Word, etc;- Extensive knowledge of applicable GCP, PV and GxPregulations, guidelines, policies and procedures;- Good knowledge of computer systems validation and 21CFR Part 11 requirements;- Ability to lead audit teams and operate successfully in various team capacities;- Excellent leadership and facilitation skills- Ability to operate successfully in various cultural environments;- Ability to deputize for Regional Audit Head as required;- Auditor certification desired.Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.**Division**Operations**Business Unit**QUALITY**Work Location**Ciudad de México**Company/Legal Entity**NOV CORPORATIVO MEX**Alternative Country 1**Mexico**Alternative Country 2**India**Alternative Country 3**Spain**Functional Area**Quality**Job Type**Full Time**Employment Type**Regular**Shift Work**No**Early Talent**No