Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. The Senior Specialist, Inspection Readiness is a site-based role at Kyowa Kirin's, Drug Substance manufacturing site in Sanford, NC, leading continuous inspection readiness and enabling sustainable regulatory compliance.
Requirements
- Develop and maintain a robust inspection readiness program aligned with global regulatory expectations.
- Lead site inspection readiness activities, including planning, scheduling, execution, and post-inspection response efforts.
- Manage regulatory inspections and requests for the Kyowa Kirin, Sanford, NC Drug Substance site.
- Maintain inspection readiness documentation (e.g., organizational charts, SOPs, training records and quality metrics).
- Manage and fulfill regulatory requests promptly to support regulatory submissions and approval status across multiple markets.
- Serve as a liaison between SMEs and RA-CMC to ensure clear and effective communication on change controls, dossier consistency, deviations, and inspection findings.
- Contribute to the generation and collection of documentation to support regulatory filings as needed.
- Design, implement, and manage electronic systems for inspection management and information sharing before, during, and after inspections and audits.
- Apply structured problem-solving techniques to resolve regulatory issues arising from deviations, change controls, or inspection findings.
- Train site personnel on Global Regulatory Affairs procedures and updates; provide mentorship and guidance across functions.
- Create 'Do's and Don'ts' training, including periodic refreshers, and cultural awareness sessions, to strengthen communication effectiveness during inspections.
- Develop targeted training programs for SMEs to enhance their ability to present effectively to investigators, tailored to the topic and investigator style.
- Stay current with regulatory guidelines for biologic products by participating in the regulatory intelligence process.
Benefits
- 401K with company matching
- Discretionary Profit Sharing
- Annual Bonus Program
- Generous PTO and Holiday Schedule
- Healthcare Benefits
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Long-Term Incentive Program
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
