Software Engineer Intern
•Tacto· 2h
EngineeringInternshipEurope
2h ago
Kyowakirinusa90·about 1 month ago
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
Technical Skills, Knowledge, and Experience
• 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.
Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Individual contributor, with responsibility to lead cross-functional project teams
Education
• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences or related field
Experience
• 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.
• Experience in drafting or reviewing regulatory documents, especially Module 3 sections, is advantageous
Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.
This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
Requires up to 10% domestic and limited international travel.
The anticipated salary for this position will be $123,300 to $161,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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