Medical Coding Team Lead at EXL responsible for auditing surgical procedures and managing coding specialists. Ensuring compliance and accuracy in medical coding within the healthcare sector.
About the role
- Lead independent GMP audits for Novartis, ensuring compliance with quality standards. Provide consultation and mentorship based on risk-based assessments and regulatory requirements.
Responsibilities
- Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations.
- Review and approve corrective action plans in support of the audit observations.
- Conduct and document GMP audits according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations and standards.
- Prepare audit reports according to NVS requirements and timelines.
- Provide technical guidance, mentoring, and training on audit activities.
- Mentor junior GMP staff as required.
- 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.
Requirements
- 12+ years broad experience in Pharmaceutical or Medical Device Industry.
- 3 years auditing experience preferred, and excellent knowledge of regulatory requirements.
- Strong knowledge of GMP regulations, sound and practical judgement in the interpretation and application of regulations and standards.
- Solid operational experience, that should include QA/QC management and manufacturing, development or other relevant experience e.g. working at a regulatory health authority.
- Strong experience in Sterile and/or expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell&Gene therapy, Radioligand therapy.
- Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.
- Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
- Fluent English, written and spoken. Other languages are a plus.
Benefits
- You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
- 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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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