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Kyowa Kirin, Inc.- U.S. · 3 days ago

Quality Systems & Compliance Senior Specialist, Inspection Readiness

Sanford, NC

Full-time

Onsite

Senior Level

$123K/yr - $161K/yr

5+ years exp

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 responsible for leading continuous inspection readiness and enabling sustainable regulatory compliance at the Sanford, NC site, ensuring adherence to regulatory expectations across all GxP areas.

Pharmaceuticals

H1B Sponsor Likely

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

Qualification

GxP complianceRegulatory inspectionsQuality AssuranceRegulatory AffairsInspection readiness programTraining developmentCultural sensitivityProblem-solvingCommunication skillsOrganizational skillsTeam collaboration

Required

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

Preferred

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

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

Company

Kyowa Kirin, Inc.- U.S.

Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.

Founded in 1949

Princeton, New Jersey, US

501-1000 employees

https://kkna.kyowakirin.com/

H1B Sponsorship

Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2022 (1)

2021 (1)