Job Description
About the Role
The Facility Inspection Manager is a critical position based at each manufacturing facility. This role collaborates between Global Operations Auditing and Site Leadership, providing key regulatory GMP knowledge and performing activities to support site inspection readiness and maintenance of site compliance.
Key Responsibilities
* Create and track site self-inspection plans, including self-inspection scheduling and development of self-inspection agendas.
* Liaise with Site Leadership and Global Operations Auditing to gain alignment on self-inspection plan schedules and scopes.
* Lead and participate in site self-inspections.
* Ensure each self-inspection is appropriately recorded and communicated.
* Perform frequent unplanned and planned walk-through inspections of facilities.
* Evaluate and track CAPA items from self-inspections and provide guidance to site functions to ensure robust, holistic actions are developed.
* Verify CAPAs 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.
Required Skills and Qualifications
To be successful in this role, you will require:
* Experience in aseptic processing, sterile product manufacturing, and cleanroom environments.
* Extensive understanding of pharmaceutical cGMP and global government regulations, including corporate policies, procedures, and associated documents (corporate, regional, site), local regulations, US FDA, WHO EMA, ICH, and ISO 9001 (as applicable to the site).
* A degree in science, engineering, or a related technical discipline, with at least 10 years' experience in a GXP setting, extending across a range of functions, including quality assurance.
* An in-depth knowledge of quality system requirements, including the ability to evaluate and apply global GMPs to support evaluation and enhancement of 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.
* 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.
Benefits
Viatris offers competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Why Join Us
Viatris is dedicated to building a truly diverse, inclusive, and authentic workplace. We believe that diversity and inclusion are essential to our mission and foster a culture that values collaboration, creativity, and innovation.