Associate Director, Quality Operations

Celgene   •  

Bothell, WA

Industry: Pharmaceuticals & Biotech

  •  

15+ years

Posted 42 days ago

The Quality Assurance Operations team at Juno is responsible for overseeing and supporting the GMP operations at the JuAssociate director,no Manufacturing Plant (JuMP) located in Bothell, WA. The Associate Director QA Operations is responsible for providing QA oversight of GMP operations and reviewing batch production and associated cGMP records to assure product quality is consistent with established standards and in compliance with regulatory and industry standards.


Primary Responsibilities include:

  • Lead and manage the day to day activities of quality assurance operations personnel and ensure the efficiency and effectiveness of all on-site quality operations activities
  • Ensure real time Batch Record review and QA approval is completed at the end of each shift
  • Provide quality assurance "on-the-floor" support, including providing guidance to Operations personnel during handling and resolution of GMP events (deviations, non-conformances and corrective actions assessment)
  • Develop a comprehensive understanding of the manufacturing processes followed for JUNO products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.
  • Observe operations, review documentation and approve incoming patient material and shipping of final drug product
  • Participate in the development and implementation of programs to ensure compliance with applicable regulatory agency requirements
  • Ensure that QA SOPs and cGMP documentation for areas of responsibility are adequate and current
  • Review and approve cGMP documentation including raw material specifications, SOPs, Master Production Records, Test Methods, protocols and reports
  • Work collaboratively with other departments to ensure compliance with cGMP processes and safety procedures for manufacturing and PLI readiness
  • Work on problems of moderate to critical scope in which analysis of the situation or data requires a review of identifiable factors, such as those exhibited in Deviation Reports
  • Support QA compliance activities such as Change Control impact assessments, deviation input including root cause determination, and CAPA deliverables
  • Create and approve relevant Standard Operating Procedures (SOP) as needed
  • Mentor Quality personnel and enable their individual growth
  • Act as subject matter expert for QA oversight of GMP operations during audits and regulatory inspections

  • REQUIRED QUALIFICATIONS
  • Minimum of 15 years working in a commercial biopharmaceutical, cellular therapy, or gene therapy industries
  • Direct experience supporting the manufacturing, testing, disposition, and distribution of cGMP products, with a minimum of 5 years prior managerial experience required
  • Experience in a QA role in a commercial biotech organization is required
  • Excellent communication, trouble shooting, and problem-solving skills
  • Excellent verbal and written communication skills
  • Strong computer skills with Word and Excel; experience with e-Systems is preferred
  • Ability to work effectively at a fast pace with cross functional departments
  • Experience interacting with regulatory agencies during inspections
  • Strong team player that can also work independently to achieve objectives


EDUCATION REQUIREMENTS

• B.S./M.S. degree in a scientific or engineering discipline or equivalent


About Us


COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE


  • At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.