Quality Systems & Compliance, Digital Lead

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 North America we are headquartered in Princeton NJ with offices in California North Carolina and Mississauga Ontario.

The Quality Systems & Compliance Digital Lead plays a critical role in ensuring adherence to global regulatory requirementsincluding 21 CFR Part 11 EU Annex 11 and data governance and integrity standardsduring the design implementation and integration of GxP computerized and automated systems at Kyowa Kirins new North American monoclonal antibody drug substance manufacturing facility in Sanford NC. Initially operating in a greenfield environment this role evolves into a key technical contributor within the Quality Systems & Compliance team driving GMP readiness technical transfer and facility licensure activities for clinical and commercial manufacturing.

As the technical quality lead you will influence compliance strategies across the lifecycle of cGxP computerized systems partnering with designated system owners and cross-functional teams to ensure validation inspection readiness and regulatory alignment. You will lead site-wide efforts to prepare for audits and inspections manage regulatory response activities and serve as a subject matter expert in automation digital platforms and data integrity. Additionally you will own training and capability-building initiatives for all site colleagues fostering a culture of quality collaboration and operational excellence.

As an individual contributor you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment always acting in line with the organizations values. By using strong interpersonal skills you will work effectively with diverse viewpoints manage relationships thoughtfully and make decisions that meet both individual and team needs. You will be accountable for delivering results adapting to challenges and helping achieve business goals. Additionally you will take ownership of your tasks act with initiative and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

This position reports to the Sr. Manager Quality Systems & Compliance

Technical Skills Knowledge and Experience
Drive the implementation and validation of automation and technology systemsincluding ERP MES LIMS and site infrastructureby aligning with global regional and site teams to meet internal and external regulatory requirements (e.g. FDA EMA ICH) uphold patient-centric principles and maintain continuous inspection readiness across all GxP areas.
Lead cross-functional collaboration across all site functions to design and execute automation strategies that accelerate digital transformation and enhance operational efficiency in manufacturing laboratory engineering warehouse and quality operations.
Designs and optimizes automated workflows to achieve business objectives ensure global regulatory compliance and optimize performance across GxP operations.
Establish and enforce the sites data governance framework by defining master data management protocols metadata standards and data lifecycle controls to ensure consistent compliant and high-quality data across all digital platforms.
Monitor and communicate progress on Quality Systems goals by delivering performance reports and presenting actionable insights to the Site Leadership Team and stakeholders enabling informed decision-making and continuous improvement.
Shape Quality IT strategies and system selection processes during early-stage site activities by defining user requirements evaluating system options and influencing procurement decisions to ensure electronic systems meet compliance and operational needs.
Ensure site-wide compliance with global data integrity standards (e.g. ALCOA 21 CFR Part 11) by leading the design implementation and integration of GxP electronic systems in coordination with Global and Regional teams aligned with approved plans and budgets.
Apply robust risk management methodologies to ensure systems comply with global regional and site procedures by documenting risk-based decisions with sound rationales factual evidence and relevant data to promote transparency consistency and audit readiness.
Partner with all site functions to achieve production targets compliantly across Manufacturing Warehouse Engineering and Laboratory areas by aligning quality processes resolving operational challenges and reinforcing adherence to regulatory standards.
Influence the QA qualification strategy for computerized systems infrastructure and automation technologies by guiding cross-functional teams and ensuring systems are validated and ready for commissioning and operational launch in alignment with regulatory and business objectives while partnering with designated CSV owners to ensure compliance.
Serve as a core member of the site-based inspection management team by leading timely compliant responses to regulatory inquiries coordinating targeted GxP refresher trainings and conducting regular walkthroughs of GxP areas to proactively identify risks and ensure continuous inspection readiness.
Deliver site-wide onboarding training and mentoring for employees and contractors in accordance with approved staffing plans by providing role-specific guidance facilitating knowledge transfer and ensuring readiness to perform in compliance with operational and regulatory standards.
Define and track key performance indicators in collaboration with Global and Regional teams to assess site performance against QMS requirements and lead periodic site management reviews with the Site Leadership Team to drive continuous improvement and ensure alignment with quality objectives.
Lead inspection readiness activities across all GxP areas by conducting GEMBA walks and readiness walkthroughs engaging cross-functional teams to proactively identify and resolve gaps and driving timely completion of action plans from audits inspections or risk mitigation efforts to ensure sustained compliance and operational excellence.

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 role with responsibility to lead cross-functional project teams

Education
Bachelors degree in Computer Science or a related scientific or technical discipline (required).
Masters degree in Computer Science or a related scientific or technical discipline (preferred).

Experience
Minimum of 8 years of experience in a GxP-regulated environment with a focus on Quality Assurance for computerized systems and digital platforms.
Demonstrated experience in computerized system validation (CSV) including reviewing system requirements protocols risk assessments and technical documentation.
Experience in data governance including master data management metadata standards and data lifecycle controls.
Proven ability to collaborate cross-functionally with Automation IT Engineering and Manufacturing teams to ensure systems are implemented and maintained in compliance with 21 CFR Part 11 EU Annex 11 and ALCOA principles.
Experience supporting greenfield or facility start-up projectsincluding GMP readiness technical transfer and inspection preparationis highly desirable.
Strong understanding of data integrity requirements electronic records/electronic signatures (ERES) and global regulatory expectations for GxP systems.
Prior involvement in regulatory inspections or audits including preparation participation and response development.
Excellent communication and documentation skills with the ability to author SOPs training materials and technical reports.
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.

Requires up to 10% domestic and limited international travel.

The anticipated salary for this position will be$137000 to $178900. 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:

• 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

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.

When you apply to a job on this site the personal data contained in your application will be collected and stored by Kyowa Kirin Inc. (Controller) which is located at 510 Carnegie Center Dr. Princeton NJ 08540 USA and can be contacted by emailing Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers recruitment related activities which include setting up and conducting interviews and tests for applicants evaluating and assessing the results thereto and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (GDPR) as necessary for the purposes of the legitimate interests pursued by the Controller which are the solicitation evaluation and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software Inc. a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controllers behalf. Accordingly if you are located outside of the United States your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR if you are located in the European Union you have the right to request access to your personal data to request that your personal data be rectified or erased and to request that processing of your personal data be restricted. You also have the right to data portability and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data you may contact us by email at .

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-SH1