Manager, Quality Assurance Operations

The Role:

ElevateBio is looking for a Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events. This individual will manage a team of QA professionals and engage with other members within operational departments as a Quality partner by providing real-time support to achieve on-time closure of quality records and disposition. A successful candidate in this position has thorough understanding of cGMP, solves problems by applying a combination of best practices and creative solutions, proactively identifies opportunities for new initiatives, and serves as a subject matter expert within Quality related functions.

Here’s What You’ll Do:

• Develop and coach team members for fostering a collaborative environment and enabling performance.
• Ensure timely delivery of final product through performance of disposition activities.
• Serve as Quality Point-of-Contact for a client program.
• Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas.
• Perform receipt and disposition of incoming patient apheresis material.
• Perform issuance verification of production documents and labels, to meet production schedule.
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Ensure all product-related Deviations are initiated, investigated, and resolved.
• Ensure that associated CAPAs are initiated and resolved.
• Perform review of quality records including lab investigations, work orders, and change controls.
• Ownership of quality records such as impact assessments, major deviations, CAPAs and change controls.
• Identify compliance risks and escalate the issues to appropriate levels of management for timely resolution.

Requirements:

• BA/BS degree with 7+ years of experience in a pharmaceutical, biotechnology or biologics operation.
• Experience in Viral Vectors, Cellular and Gene Therapy Products is desired.
• Working knowledge and ability to apply GMPs.
• Strong teamwork and collaborative skills.
• Experience with manufacturing investigations, deviations, and CAPA.
• Experience with change control practices and strategies.
• Strong knowledge with aseptic manufacturing processes is preferred.
• Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.