Quality Systems & Compliance Senior Specialist, Inspection Readiness

Kyowa Kirin North America•Sanford, NJ

26d•Onsite

About The Position

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. 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. This role is instrumental in designing, implementing, and maintaining the site’s inspection readiness program, ensuring compliance with regulatory expectations across all GxP areas. The Sr. Specialist will lead inspection planning and execution, manage regulatory requests and serve as a key liaison between site Subject Matter Experts (SMEs) and Global Regulatory Affairs, primarily RA-CMC. As a member of the Quality Systems & Compliance team, this role leads GMP readiness, executes regulatory submission activities, and prepares quality documentation. Additionally, this role will develop site level reports, create training materials, and drive continuous improvement initiatives that strengthen regulatory and operational excellence. This position reports to the Sr. Manager, Quality Systems & Compliance

Requirements

Bachelor’s degree in Life Sciences, Pharmaceutical Sciences or related field
At least 5 years of experience in a GxP-regulated environment, with a focus on Quality Assurance, or Regulatory Affairs.
Proven experience leading regulatory inspections programs, internal audits, and mock inspections.
Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE.
Requires up to 10% domestic and limited international travel.

Nice To Haves

Experience in drafting or reviewing regulatory documents, especially Module 3 sections, is advantageous

Responsibilities

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. Responsibilities include inspection preparation, team coordination, managing responses, and monitoring inspection trends.
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 (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well-Being and Work/Life Programs
Long-Term Incentive Program (subject to job level and performance)
Life & Disability Insurance
Concierge Service
Pet Insurance
Tuition Assistance
Employee Referral Awards