Description:
Responsible for oversight of Corrective and Preventive Actions (CAPA) to support medical devices, Media FFM, and cell therapy products. Individual should be able to work independently with little direction to prepare written and verbal communication. The individual is expected to interact with Bioscience and Cell Therapy Management, QA and Operations leadership. Primary responsibility is oversight of the creation, closure and evaluation of the effectiveness of CAPA documents for the aseptic processing of Bio therapeutic and Research media, Medical Devices and Cell Therapy operations. Risk assessing deviations at the Deviation Review Board is also a primary responsibility. Strong knowledge and experience in aseptic drug product manufacturing regulations and medical device quality management system regulations is required. Experience in quality oversight of aseptic manufacturing.
Manage staff of at least one PR Coordinator to support review of CAPAs and associated deviations.
Ensure that current CAPA standard operating procedures meet the requirements of US and international regulations for drugs and medical devices including 21CFR820 and ISO 13485. Review deviation and CAPA trends. Review and assess new deviations to determine risk rating. Escalate major and critical deviations to site QA Director and Site Director. Continuously assess the health of the system and escalate adverse trends to quality and operations management.
Provide oversight of the issuance, completions and effectiveness of all CAPAs opened to support deviations, audit responses, regulatory observation remediation or regulatory gap assessments for Media, Cell therapy and LAL deviations, CAPAs and Complaint handling. Manage oversight of quality related deviations, complaints to ensure these records are escalated, investigated and appropriate CAPAs are opened. Ensure that CAPAs are properly completed and documented evidence is included. Assess effectiveness of CAPAs.
Supports regulatory or client audits as Deviation/CAPA subject matter expert.
Develop and approve cGMP documents including, but not limited to, SOPs, batch records and specifications. Ensure process is efficient and effective.
Requirements:
7-10yrs QA experience
10 yrs GMP experience
5 yrs in a Management capacity