Audit & Compliance Professional

Band Level 4

Job Description Summary The Audit & Compliance Professional manages cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators). Performs preparation and management of external and corporate audits and Health Authority inspections.

Major Accountabilities:

- Plan, lead, conduct, document, report, and follow-up of GMP audits according to the requirements specified in the respective Novartis procedures as well as applicable regulations, standards, quality agreements, and guidance documents.

- Audits will be focused to mid-low risk manufacturing and other GMP activities, on the basis of actual experience/expertise.

- Provide technical guidance and training on audit activities.

- Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.

- Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.

- Maintain current knowledge of regulations, standards, and guidance documents.

Essential requirements:

- Degree in Chemistry, Pharmacy, Biology, Engineering or another related science.

- At least 10 years broad experience in Pharmaceutical or Medical Device Industry including QA/QC management and manufacturing, development or other relevant experience e.g. working at a regulatory health authority.

- 3 years auditing experience preferred and excellent knowledge of regulatory requirements. Willingness to travel approx.60% of the time.

- Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.

- Strong interpersonal skills and fluency in English, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.