Quality Assurance Lead, Internal Audit

Job Description

#2577 Quality Assurance Lead, Internal Audit

Company is a Fortune 500 pharmaceutical company. This is a global company that discovers, develops, manufactures and branded prescription medicines. They operate worldwide and are known for breakthrough drugs and innovative therapies with a commitment to global health access.

Quality Assurance Lead, Internal Audit will make an impact by:

• Creation and tracking of the site self-inspection plan, inclusive of self-inspection scheduling and development of self-inspection agenda.
• Liaising with Site Leadership and Global Operations Auditing to gain alignment on self-inspection plan schedule and scope.
• Leading and participating in site self-inspections. Ensuring each self-inspection is appropriately recorded and communicated. Performing frequent unplanned and planned walk through inspections of the facility.
• Evaluation and tracking of CAPA items from self-inspections and providing guidance to site functions to ensure robust, holistic actions are developed. Ensuring that CAPAs are verified for effectiveness.
• Prepare annual trend reports for site self-inspection data and collaborate across Viatris to identify Global and/or regional opportunities. Facilitate bi-monthly reviews with site and global personnel to discuss site learnings and opportunities.
• Responsible for Site Audit Module and associated processes and procedures.
• Support overall site Inspection Readiness Plan, participating as required in site Board of Health inspections.
• Participate in Global Operations Audits of Viatris facilities.
• Perform external audits of third party suppliers as aligned with site and GOA requirements.
• Participate in global audit training and disseminate relevant detail to site teams. Provide training and coaching as required to broader site self-inspection team.
• Support any of the site quality culture initiatives.

The minimum qualifications for this role are:

• Must possess extensive knowledge and understanding of pharmaceutical cGMP and global government regulations, including Viatris policies, procedures and associated documents (corporate, regional, site), local regulations, US FDA, WHO EMA, ICH and ISO 9001 (as applicable to the site).
• Possess an in-depth knowledge of quality system requirements; including a demonstrated ability to evaluate and apply global GMP’s to support evaluation and enhancement to site systems and processes.
• Minimum of a Bachelor's degree in Science, Engineering, or related technical discipline with at least 10 years’ experience in a GXP setting, extending across a range of functions inclusive of Quality Assurance. However, a combination of experience and/or education will be taken into consideration.