Audit and Compliance Professional

Job Description Summary

In this role you will manage 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). You will perform preparation and management of external and corporate audits and Health Authority inspections.

Job Description

Major accountabilities:

• Lead evaluation of internal and external GLP/GCP laboratories QA oversight of processes across the organization for the identification of risks and potential gaps and/or regulatory requirements. Work effectively in a matrix environment with stakeholders to prioritize, develop, and implement plans to address these gaps and ensure sustained compliance.
• Interact with internal and external functions to support implementation of activities from regulatory intelligence that impact the organization.
• Establish quality oversight program for audit actions/deviations/incident management pertinent to GLP/GCP laboratory activities. Ensure implementation of effective KQIs. Pro-actively reviewing outcomes/trends to sustain improvement and ensuring timely escalation when required.
• Lead GLP/GCLP inspections and assist in the surveillance inspections as assigned. Interact as required with regulatory agencies regarding GLP/GCLP matters.
• Prepare and ensure execution of the audit plan of internal GLP/GCLP activities, facilities and computerized systems including Report Amendment Audits.
• Establish, lead, and implement GLP/GCLP regulatory training program(s).
• Support the creation or revision of Quality SOPs.
• Support the preparation of the annual third party GLP/GCLP laboratory audits and monitoring plan in collaboration with Third Party Management QA oversight.
• Support/lead audits and inspections follow-up activities including CAPA preparation, review, effectiveness and closeout activities.
• Participate/lead internal projects and contribute to the implementation of continuous improvements.

Obligatory Requirements:

• Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience)
• 7+ of practical experience in pharmaceutical industry (e.g., preclinical safety, GLP/GCLP, bioanalytics, in-vitro studies or related area).
• Min. 5 years of practical experience in any quality management system (e.g., GxP)
• In-depth knowledge of Industry Quality Standards and International Regulations (OECD, FDA, EU) and and computer system validation
• Expertise in the conduct of internal and external quality inspections and audits
• Excellent knowledge of the different kinds of safety assessment studies
• Strong leadership experience including excellent communication, collaboration/consensus building, considerable organizational awareness, influencing and negotiation skills.
• English fluent, written and spoken

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and tru ste d medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: and culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. rewards Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis an d o ur career opportunities, join the Novartis Network here:

Skills Desired

Auditing, Audit Management, Communication Skills, Compliance Audits, Compliance Risk, Continuous 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 #J-18808-Ljbffr