At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the (Self Inspection Lead) role will make an impact:
POSITION PURPOSE
The Site Self Inspection Lead is a critical role based at each manufacturing facility to collaborate between Global Operations Auditing and Site Leadership, providing key regulatory GMP knowledge and performing activities to support the site inspection readiness and maintenance of the site compliance.
Key activities will include:
Leading and/or participating in all site self-inspections, ensuring each activity is appropriately recorded and communicated.Performing frequent unplanned and planned walk through inspections of the facility.Managing the self-inspection program, inclusive of scheduling, tracking, CAPA development and effectiveness verification, coaching and training of other self-inspectors.Supporting 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.This position will work with a high level of independence and actively coordinate/participate in activities with Global functions across Viatris.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
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.Perform other duties as required by management.EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
Extensive 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).Minimally Primary or Higher 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.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.Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision.Comprehensive and demonstrated written and verbal communication skills are required.Demonstrated ability to negotiate and collaborate with individuals and groups at multiple levels across the organization including senior leadership of various functional lines across Viatris.SUPERVISION
Position has no direct supervision responsibilities, however provides direction, training and coaching to others across the site in order to facilitate the site self-inspection activities.
LICENSES/CERTIFICATIONS
None required, audit qualification or training desired.
LANGUAGE SKILLS
Strong command of written and spoken English is essential. Local language as required for specific site is essential.
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors to communicate ambiguous concepts. Ability to present to groups across the organization.
MATHEMATICAL SKILLS
Ability to solve equations, apply mathematical concepts, and perform computations.
REASONING ABILITY
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
PHYSICAL DEMANDS
Light or no physical demands. Minimal handling of light materials and tools.
Travel Expectation: Some travel expected. Potential for travel up to 20% of time.
WORK ENVIRONMENT
Typical daily environment, light or no physical demands. Minimal handling of light materials and/or tools. Very good working conditions. No unusual health hazards, follow all applicable site health and safety requirements at home site and when visiting other site locations. Safety precautions may be required such as safety glasses, ear protection, protective clothing, etc. when performing audit activities.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.