Senior Audit & Compliance Expert

Job Description Summary

The Senior Audit & Compliance Expert 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.  

 

Job Description

Major accountabilities:

• Act as a Program/Project Manager for the Quality Stream linked to main projects at site level.

• Act as CAPA Plan and Remediation Plan Program/Project Manager ensuring the respect of the timeline, assess and prevent any potential interferences between projects and CAPA/Remediation plans.

• Oversight of all production and testing activities, ensures compliance with cGxP, including data integrity and eCompliance with specific focus on Quality Workstream for the main projects on site.

• Support exception investigations.

• Review and approval of production, QC and AS&T records.

• Support site qualification and validation activities (planning, advising, review).

• Implementation of Quality Systems (incl. documentation management).

• Supplier management activities (agreements, oversight, audit).

Essential requirements:

• Scientific degree.

• Solid previous experience in a QA Compliance department within the pharmaceutical industry.

• Project management skills.

• Fluent in Italian and English.

 

Skills Desired

Auditing, Audit Management, Communication Skills, Compliance Audits, Compliance Risk, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management and Leadership, Qa (Quality Assurance), Regulatory Compliance, Risk Management, Self-Awareness, Technological Expertise