Sr International Auditor

How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.
1. Coordinates, plans, and conducts audits, issues audit reports and reviews and approves cor-rective action plans for CPOs, Clinical Investigator Sites, Pharmacovigilance Systems and CROs/Labs/Licensing Candidates/
2. Coordinates inspectional activities, including investigator, sponsor/monitor/CRO, and IRB/EC inspections both locally and abroad.
3. Provides interpretation of GCP regulations, guidelines, policies and procedures, and provides sound guidance to Novartis personnel and contracted service providers, both verbal and writ-ten.
4. Provides regulatory/compliance guidance and interpretation and the ability to represent CQA in internal and external meetings and deputizing for the group head as needed.
5. Develops and implements GCP training programs as needed; also provides training within CS&E as needed.
6. Participates in process improvement initiatives, ie SAfE program
7. Participates and or supports audits or projects with other line functions including but not limited to CDO, GQO, CDMA etc
8. Interacts, facilitates and educates line functions within CDMA, as well as clinical site person-nel, CRO/vendor, personnel, etc on various aspects of compliance.
9. Researches, proactively local and international initiatives, trends and events in order to main-tain compliance.
10. Participates in conducting route cause investigations and monitoring corrective actions for late health authority case reports. Conduct formal investigations of issues as they arise.
11. Manages CPO post-audit form QA perspective including but not limited to the review and approval of CAPs, reports, investigations and procedures. Performs timely entry of audit met-rics and root causes of non-compliancesQualifications
Experience/Professional requirement:

Three years plus of clinical/industry/health authority ex-perience;

Three year+ of Good Clinical Practices auditing experi-ence;

40% travel;

Proficiency with basic computer skills, including Lotus Notes, Word, etc;

Excellent verbal and written communication skills, team player, interpersonal skill;

Expert in pharmacovigilance and GCP/ICH regulations, as well as versed in Novartis SOPs, WPs, and NIPs;

Prior coordination of HA inspections especially FDA;

Ability to multi-task and function independently as re-quired; able to mentor and lead teams;

Flexible and proactive in learning new audit techniques

Knowledgeable in computer validation and Part 11 re-quirements;

Auditor certification (ASQ);

Ability to operate successfully in various team capacities, including leader and/or active member.
Life science degree or equivalent
Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.