Director Quality Control

TakedaAR
90d$174,500 - $274,230

About The Position

Located just outside Atlanta, Takeda’s state-of-the-art manufacturing facility in Covington is one of the largest biotech production sites in the world. As a pivotal part of Takeda’s global manufacturing network, the Covington site plays a key strategic role in supplying high-quality plasma-derived therapies to patients worldwide. Equipped with advanced technology and modern processes, the facility supports ongoing innovation, helping to drive Takeda’s growth and mission to deliver life-changing medicines. As our Quality Control Leader, you will play a pivotal role in guiding and supporting all quality control activities at our site, encompassing analytical chemistry, microbiology, and adherence to laboratory best practices. Your work will be crucial in ensuring we meet high standards for product safety, compliance, and continuous improvement. You’ll report directly to the Site Quality Head and be a visible champion of Takeda’s Quality Culture.

Requirements

  • Bachelor’s degree in science, engineering, or a related technical field (or equivalent experience).
  • At least 10 years of relevant experience, including 7+ years in a leadership role.
  • Strong background in managing large, multi-function laboratories and extensive experience in Analytical Chemistry.
  • Solid understanding of regulatory requirements (FDA, EMA, cGMP, GDDP).
  • Experience managing regulatory inspections and audit readiness.
  • Familiarity with laboratory testing for endotoxin and sterility (preferred).
  • Effective at managing budgets and team development.
  • Experience with digital and process improvement initiatives.

Responsibilities

  • Lead and manage the Quality Control (QC) Laboratory, including the Analytical Chemistry and Microbiology teams.
  • Develop and uphold quality control processes to guarantee product safety and compliance.
  • Manage a QC team responsible for 24/7 testing of raw materials, intermediates, and finished products.
  • Ensure all operations meet internal and external (regulatory) quality standards and stay current with new requirements.
  • Hire, develop, and recognize technical staff; foster a culture of growth and acknowledgment.
  • Serve as a key advisor and handle technical issues and scheduling for the QC team.
  • Evaluate the effectiveness of quality control activities with site leadership.
  • Lead and drive continuous improvement initiatives focused on quality, reliability, and cost savings, including digital projects.
  • Manage the budget for the QC department.
  • Develop and maintain the site contamination control program with a focus on sterility assurance.

Benefits

  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • Health & Wellness programs, including on-site flu shots and health screenings
  • Generous paid time off for vacation, sick leave, and volunteering
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Professional development and training opportunities
  • Tuition reimbursement
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