Kyowa Kirin North America

Kyowa Kirin North America

Quality Engineer, Lead (QS&C)

Sanford, NC

Sponsorship not specified$129k-$177kDetected 44 days ago
ComplianceGMPLeadershipCollaborationProblem SolvingOrganizational SkillsGxP

About the role

  • 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.
  • This role independently prepares, presents, and defends Quality Engineering approaches and evidence during regulatory inspections, internal audits, and external audits.
  • Reporting Relationship: This position reports to the Sr.

Responsibilities

  • Strong interpersonal skills, acknowledging diverse viewpoints, and building cross functional relationships will be the key driver to make decisions that meet both individual and team needs.

Requirements

  • Bachelor's degree in engineering or science related field required.
  • Demonstrated experience in qualification, validation, change control, and Quality Engineering activities.

Nice to have

  • Master's degree in engineering or science related field considered a plus.
  • Minimum 8 plus years of direct industry experience in a GxP-regulated environment with a focus on Quality Engineering
  • including demonstrated experience serving as a Quality SME during regulatory inspections and/or audits.
  • Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms highly preferred
  • Familiarity with DS single-use biologics operations or greenfield startup environments is preferred.

Compensation

  • The anticipated salary for this position will be $129,000 to $177,300.

Benefits

  • Annual Bonus Program (Sales Bonus for Sales Jobs)

Company info

  • Other standard company policies for flexible work arrangements do not apply to this role.
  • 401K with company matching
  • The Sanford site is the first production facility in North America, and we are headquartered in Princeton, NJ, with offices in California 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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