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Site Compliance Manager
2 weeks ago
At Viatris, we see healthcare as it should be.
We act with courage and are a source of stability in evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
- Access – Providing 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.
Our global portfolio includes best-in-class products and services across a wide range of therapeutic areas.
We help create healthier communities through education, outreach and better access to treatment.
This role is ideal for individuals who can lead by example and foster a culture that drives courage and resilience.
The Role & What You Will Be Doing
You will ensure GMP compliance and inspection readiness at the manufacturing site. Key duties include leading self-inspections, conducting facility walk-throughs, managing the self-inspection program (scheduling, CAPAs, training), supporting regulatory inspection readiness, participating in global audits, and auditing third-party suppliers.
This role acts as a key link between Site Leadership and Global Operations Auditing.
This position requires high independence and active coordination/participation with Global functions across Viatris.
Key Responsibilities:
- 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.
About Your Skills & Experience
We're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
- Minimum of a primary or higher degree in Science, Engineering, or related field with 10+ years' experience in GXP environments, including Quality Assurance.
- Strong understanding of cGMP and global regulatory requirements (FDA, WHO, EMA, ICH, ISO 9001), including Viatris policies and procedures.
- Proven leadership, accountability, and strong organizational skills; capable of working independently.
- Deep knowledge of quality systems and ability to apply global GMP standards to improve site systems and processes.
- Skilled in negotiation and collaboration with stakeholders at all levels, including senior leadership across Viatris
- 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.
- Audit qualification or training desired.
- Some travel expected. Potential for travel up to 20% of time.
Sustainability and Diversity at Viatris
Viatris is committed to advancing responsible and sustainable operations and leveraging our collective expertise to empower people to live healthier at every stage of life. We recognize that our actions affect the stakeholders and communities we serve.
Benefits
At Viatris, we offer 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.
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