Audit and Compliance Professional

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: https://www.novartis.com/about/strategy/people and culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits 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: https://talentnetwork.novartis.com/network