Key Site Compliance Specialist
21 hours ago
Key Site Compliance Specialist
This is an exciting opportunity to lead and develop site self-inspection programs, ensuring compliance with Good Manufacturing Practice (GMP) regulations and inspection readiness. As a Key Site Compliance Specialist, you will be responsible for creating and tracking site self-inspection plans, scheduling and conducting self-inspections, managing CAPAs, supporting regulatory inspection readiness, participating in global audits, and auditing third-party suppliers.
The ideal candidate will have a strong understanding of cGMP and global regulatory requirements, as well as excellent leadership, organizational, and communication skills. They will be able to work independently and collaboratively with stakeholders at all levels, including senior leadership.
Responsibilities:- Lead and Develop Site Self-Inspection Programs: Create and track site self-inspection plans, inclusive of self-inspection scheduling and development of self-inspection agendas.
- Ensure GMP Compliance and Inspection Readiness: Conduct self-inspections, manage CAPAs, support regulatory inspection readiness, participate in global audits, and audit third-party suppliers.
- Collaborate with Stakeholders: Work closely with site leadership, global operations auditing, and other stakeholders to ensure alignment on self-inspection plan schedules and scopes.
- Develop and Track Trends: Prepare annual trend reports for site self-inspection data and collaborate across the organization to identify global and regional opportunities.
- Support Global Operations Audits: Participate in global operations audits of facilities and perform external audits of third-party suppliers as aligned with site and GOA requirements.
- Provide Training and Coaching: Provide training and coaching to site teams on self-inspection best practices and ensure that relevant information is disseminated to broader site teams.
- Minimum Qualifications: Primary or higher degree in Science, Engineering, or related field with proven experience in GXP environments, including Quality Assurance.
- Strong Understanding of cGMP and Regulatory Requirements: Strong understanding of cGMP and global regulatory requirements, including Viatris policies and procedures.
- Leadership and Organizational Skills: Proven leadership, accountability, and strong organizational skills; capable of working independently and collaborating with stakeholders.
- Communication and Collaboration Skills: Excellent written and spoken English skills; ability to read and interpret complex business and technical documents, write comprehensive reports, and present to groups.
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