QA Compliance Team Leader

Job Description Summary

The QA Compliance Team Leader supports 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).
Supports the preparation and management of external and corporate audits and Health Authority inspections.  

 

Job Description

Major accountabilities:

• Planning and supporting PQR/APQR activities.

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

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

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

• Preparation/support and coordination of CAPA/follow-up.

• Audit and inspection preparation and support.

• Change control review/approval.

• Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.).

• Ensure process quality assurance according to regulations.

• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.

Minimum Requirements:

• Scientific degree.

• Previous experience in a Quality Assurance department within a pharma manufacturing environment.

• People management skills.

• Fluent in Italian and English.

 

Skills Desired

Action-Oriented, Compliance Requirements, Continued Learning, Dealing With Ambiguity, Functional Skills, Gmp Procedures, Gxp, Industry Standards, Process Optimization, Qa (Quality Assurance), Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence