Kyowa Kirin North America

Kyowa Kirin North America

Senior Specialist, Quality Engineer

Sanford, NC · Senior

Sponsorship not specified$116k-$152kDetected 20 hours ago
ComplianceProcess ImprovementGMPCollaborationProblem SolvingOrganizational SkillsGxP

About the role

  • 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.
  • Our collective goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, from drug discovery to product development and commercialization.
  • The Senior Specialist, Quality Engineer is a key individual contributor role within the Quality Systems &Compliance team supporting quality and compliance during the startup and operation of Kyowa Kirin's Sanford, NC Greenfield site.

Requirements

  • Bachelor's degree in Life Sciences, Pharmaceutical Sciences or related field
  • Demonstrated experience in qualification, validation, change control, and Quality Engineering activities.
  • 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.

Nice to have

  • Minimum 5 plus years of direct industry experience in a GxP-regulated environment with a focus on Quality Engineering
  • Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms highly preferred
  • Familiarity with single-use DS biologics operations or greenfield startup environments is preferred.

Skills

  • Respond promptly, take accountability, and manage tasks efficiently.
  • Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.
  • 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.
  • This position reports to the Sr.

Compensation

  • The anticipated salary for this position will be $116,000 to $152,300.

Benefits

  • 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
  • Life & Disability Insurance
  • Tuition Assistance

Company info

  • Other standard company policies for flexible work arrangements do not apply to this role.
  • 401K with company matching
  • In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Visa & Work Authorization

  • ability, 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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This listing is sourced directly from Kyowa Kirin North America's careers page and normalized into a canonical job model.