QA Lead, Operations; Cell Therapy; W

Job Summary

Cellipont Bioservices is growing, and we are looking for a QA Lead, Operations who believes in the potential of bridging clients’ discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.

The QA Lead, Operations will be the main point of contact for assigned client projects, supporting commercial readiness activities, managing relationships, and driving project deliverables. This individual will be responsible for preparing detailed project schedules, including the identification of major milestones for overseeing, controlling, communicating, and managing all activities required to complete client projects as they pertain to QA lot release and assigned commercial readiness activities.

The QA Lead, Operations will oversee batch record review, and lot release deliverables that are client-focused, results-oriented, performance-driven, and in compliance with all applicable internal and external requirements and monitor projects and help resolve issues or elevate, appropriately, to ensure on-time delivery of all client’s projects with management of effective risk mitigation plans and stakeholder communication. This individual will provide QA support for new product introductions at the site.

This role will also require the individual to demonstrate a strong ability to work cross-functionally and possess strong leadership skills.

• Primary responsibility is to provide QA oversight and support to client projects while working closely with QA Management to ensure QA support for GMP operations for the manufacture of cellular therapies.
• Represents QA in client interactions and meetings.
• Works cross-functionally with Project Management, AD/PD, Supply Chain, Manufacturing, F&E, and Quality Control to execute client project activities timelines.
• Identify compliance risks and elevate to management with remediation proposal and lead solution implementation.
• Guides the successful completion of major programs and may function in a project leadership role.
• Conducts review/approval of master batch records, executed batch records in real-time, and supporting documentation for accuracy, completeness, and compliance as required.
• Act as the first responder for all manufacturing quality issues and interfaces with the client to gain resolution.
• Supports GMP departments in performing and documenting deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and identifying/implementing effective corrective and preventive actions (CAPAs).
• Provide training for new or revised quality processes.
• Supports and/or leads client on-site audits and participates in on-site technical visits.
• Support regulatory (i.e. FDA, EMA) inspections.
• Maintains systems used for tracking various GMP manufacturing-associated support activities.
• Generation and/or revise SOP documents following cGMPs.
• Assists in managing the Quality programs and systems to ensure compliance with Quality requirements and provides advice on GMP-related issues.
• Stay current, and be able to interpret changes to current Good Manufacturing Practices, including FDA, EU, and other regulatory bodies (relevant to Cellipont Bioservices activities) and guidance bodies including ICH, ISPE, etc.

• BS. in a Life Sciences discipline with a minimum 8 years of experience within the biopharmaceutical or regulated pharmaceutical industry (previous CDMO experience is a plus) and at least 6 years of experience in Quality Assurance.
• Strong technical and quality background related to biological manufacturing (preferably Cell Therapy)
• Strong familiarity with commercial GMP processes within biologics. Experience with transitioning products from clinical to commercial processes and process validation is preferred.
• Ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
• Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
• Provides technical solutions to complex problems which require the regular use of ingenuity and creativity
• Ability to quickly learn new and novel manufacturing processes supporting new clients
• Able to work in a team setting and independently under minimum supervision
• Familiarity with electronic systems, including developing and producing reports using Smartsheet and Excel
• Requires the ability to produce quality results in a fast-paced environment to meet client deadlines
• Able to communicate effectively orally and written with all levels of personnel and regulatory inspectors

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the…