QC Senior Manager, Lab Support (12 month fixed term contract)

Position Summary The Senior QC Manager will be responsible for the oversight of QC Medical Device, QC Incoming Inspection, QC Sample Management, QC Document Coordination, and QC Laboratory Coordination roles. This role will involve ensuring compliance with quality standards, maintaining accurate documentation, and supporting the efficient operation of the QC laboratory. Principal Responsibilities Management and supervision of the QC Medical Device team and activities including oversight on method validation and transfer activities for new device introduction. Oversight on clinical and commercial QC testing of Medical Device to support market requirements Oversight of the incoming inspection process for components, Drug product, medical device constituents and anything else required to support the packaging line. Ensure that incoming materials meet quality specifications and regulatory requirements. Collaborate with cross-functional teams to support NPI and address any quality issues related to incoming materials Oversee the documentation lifecycle process for quality control activities, including archiving onsite and offsite as required and maintaining adequate inventory for QC archived documents. Coordinate the daily activities required to support the QC lab coordinator role with oversight of reagent management, PO generation and invoice approvals. Foster a culture of collaboration, teamwork, and continuous improvement within the QC laboratory. Support all internal and external Audits and Inspections (GMP and Medical Device) Represent QC at internal and external meetings Keep management informed on KPI’s and potential issues withing the team Any other responsibilities as directed by QC Director Qualifications and experience Minimum 10 years’ experience Proven experience in a leadership role Thorough understanding of quality control principles, regulatory requirements, and best practices in documentation management. Strong organizational skills, attention to detail, and the ability to effectively prioritize and manage multiple tasks. Excellent communication and interpersonal skills, with the ability to collaborate with cross-functional teams and drive quality initiatives. Education Bachelor's degree in a scientific discipline or a related field. (Advanced degree or relevant certification is a plus.) AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

#J-18808-Ljbffr