Senior International Auditor/ CQA

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Job Purpose (State in one sentence the overall objective of the role)Responsible for review and approval of validation deliverables, conducting vendor audits and pro-viding training, leading remediation teams and providing consultancy services to customers across CS&E, CDMA and ED in Development, helping to ensure regulatory compliance and proposing workable solutions to complex systems issues.Major Activities (Describe main activities)1.Ensures that Novartis GxP systems are in compliance with applicable regulations, guidance, and Novartis Quality Modules and Policies, via a program of review and approval of validation documentation and the support of IT project team and operational application support.
2.Conducts vendor audits of GxP system suppliers and Novartis internal, "clinical" computer-ized systems (including, but not limited to, CDMA, CDO, DRA, DIT, CP and CS&E).
3.Develops materials and provides training on applicable regulations, guidance, validation and auditing, as well as serving as a consultancy resource for the sector, team participation on key areas.
4.Stays abreast of changing technologies and provides guidance/training to personnel in the clinical milieu on the impact of those new technologies on regulatory compliance, and poten-tial areas of new or changing responsibilities, workflows and business processes.
5.Represents CQA/CS&E on compliance and regulatory committees and task forces as assigned.
6.Supports product/process inspections, investigations of CQA departmental initiatives.
7.Leads complex IT system remediation activities and supports the implementation of inter-departmental IT systems.
8.Interacts with Health Authorities on e-systems compliance activities.Qualifications
Life Science Degree or equivalentEnglish

Minimum 5 years experience in the pharmaceutical industry, with a minimum of 2 years in QA, IT, programming or validation

Previous experience or training in computerized system validation, and auditing.

Strong industry experience in the area of GCP, GMP and pharmacovigilance

Ability to lead cross-functional project teams

Strong oral and written communication and negotiation skills required.
Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.