QA Manager

3 weeks ago

Philadelphia, United States System One Holdings, LLC Full time

Title: QA Operations ManagerLocation: Onsite, Philadelphia PA Schedule: M-F 8am-5pmType: Direct/PermanentCompensation: Competitive salary with an excellent benefits packageStart date: ImmediateOverview: Join our dynamic team as a QA Operations Manager for a Contract Development and Manufacturing Organization (CDMO) you will play a key role to ensure quality processes, improvement and requirements are met for products developed and produced. Responsibilities: Responsible for the establishment and implementation of QA Operations activities and governing proceduresResponsible for compliant, thorough, and accurate batch review activities, including QC analytical data and other ancillary batch documentation.Perform batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control and investigationManage the QA communication and lot disposition process with CDMO client base.Ensures proper training and qualification of all quality assurance associates in team.Manage QA resources "on the floor" in each of the areas to perform the QA function and provide real-time and direct review, approval, or feedback for the operations.Review and approve documentation generated, including master batch records, specifications, protocols, and reportCreate, review and approve product specifications, certificates of analysis, and stability protocols/reports.Oversees material and product label printing and ensuring regulatory requirements are being met.Ensures that critical materials used in the manufacture of cellular immunotherapies and gene therapies, are sourced appropriately, received and tested according to approved standards,and provides the disposition of these materials.Supports the vendor qualification program through audits, training, and provides SME where necessary.Provides QA oversight of shipping and receipt of critical materials or final product.Monitoring of process and product related Key Quality Indicators Verifies data integrity across the operations units.Participates and supports internal, client and regulatory audits to ensure compliance to all relevant policies and procedures as requiredProvides quality in-put into product- or process-related deviations, change control, audits/inspections.Ensure consistency of quality related processes and procedures within the Operations Units. Performs other job functions as directed by the Head of QA. Requirements: BS in Life Sciences, pharmacy, or equivalent; advanced Life Sciences Degree preferred5+ years of experience in Quality Assurance with demonstrated leadership skills, and a strong focus in GMP QualityProficiency with interpreting and implementing GXPs, FDA, EMA, ISO and ICH regulations and guidelinesExperience with Preclinical to commercial product development and experience in biologics preferredAttention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendorsCritical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision makingStrong technical writing skills (must be able to write investigations and SOP's)Prior experience with batch record review and releasing batchesAttention to detail and the ability to work individually, within a multi-disciplinary team, as well as with clientsThrive in a fast-paced, innovative environment remaining flexible, proactive, resourceful, and efficient

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