Lead Specialist ,Technical Quality

Oxford Biomedica
Durham, NC
Job Description
Join OXB in changing lives by enabling life-changing therapies to reach patients around the world. As a Lead Specialist, Technical Quality, you will support the TQ organization through coaching/guidance and quality oversight review, and reports related to process manufacturing and laboratory equipment qualification, technology transfer, and process validation.

Requirements

  • Lead, facilitate and/or participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
  • Participate in investigations and risk assessments related to deviations/ complaints and changes
  • Participate in project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release.
  • Provide Technical QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
  • Provide Technical QA oversight to the qualification/validation, technical transfers, aseptic processing, regulatory approvals and commercial/clinical operations at the facility.
  • Review and Approval of validation lifecycle documents and reports.
  • Quality oversight of validation activities, for life cycle approach, following validation plans and complying with cGMP regulations and company procedures.
  • Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
  • Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements.
  • Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
  • Participate in and support risk management activities in line with relevant guidance and best industry practice.
  • Assist in the execution of the internal audit program including the performance of audits are required.

Benefits

  • Competitive total reward packages
  • Wellbeing programs that support your mental and physical health
  • Career development opportunities to help you grow and thrive
  • Supportive, inclusive, and collaborative culture
  • State-of-the-art labs and manufacturing facilities
  • A company that lives its values: Responsible, Responsive, Resilient, Respect
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