The Senior Manager/Manager serves as a QCFU resource for managing the compliance of CMOs (Cell banking, Bulk Drug Substance, Packaging/Labeling) and external testing labs to ensure product and associated data adheres to cGMPs, EMEA, ICH and JP regulations, and Client requirements. This role participates in the resolution of CMO operational issues, maintains an effective working relationship with CMO’s and internal team members, tracks quality related issues, and participates in CMO business meetings as required.
This position works with DI+, PMCFU, and Exton CMC Program Management on a day-to-day basis to ensure review and approval of internal/ external deviations and change controls, master and executed production batch records, test methods, release specifications, qualification/ validation/ stability protocols and reports, quality agreements, reference standard implementation, and BLA/IND/IMPD documentation.
This role is responsible for batch disposition and supporting external audit activities, where required.
This position works independently to ensure processes and products produced in the development and commercial phase within adhere to international GMP requirements. The decision-making scope of this position requires the person to determine suitability of product for further processing and eventual use in clinical and commercial product.
This position will support the creation and improvement of Quality Systems, while ensuring seamless and efficient efforts are applied to project activities.
This role ensures compliance with established policies and procedures.
1. Assess suitability of cell banks, bulk drug substance, and packaged / labeled drug product for further processing and eventual use clinical and commercial product
2. Ensure CMO compliance to international GMP regulations as well as Client expectations including trending and evaluation of issues for impact to product on a continual basis as well as external audit support
3. Support review of technical protocols, reports, batch records and regulatory documentation (BLA/IND/IMPD) with emphasis on adherence to agreed quality systems and international regulations
4. Support review of deviations, OOS, and change controls affecting both internal and externally approved processes/ products including corrective action recommendations and approval of final actions
5. Develop, implement and maintain processes and procedures to support quality systems specific to the CMO interactions; Ensure processes and procedures are adhered to, consistent with GMPs, and value-added.
• B.S. in Science related field (or equivalent)
• Minimum of 3 years of drug/biotech experience
• Minimum of 5 years of quality auditing in GLP, GMP and/or ICH/GCP environment
• Knowledge and experience with all aspects of Quality System Management, lot disposition, deviation and investigations, CMC participation, training, and auditing
• Thorough working knowledge of regulated GMP systems as well as FDA, EMEA, ICH and JP regulations
• Ability to effectively communicate verbally and in writing
• Collaborative working style (internal and external) with supervisory experience
• Flexible in working with associates from all departments and organizational levels, including external partners, while meeting commitments
• Experience with requirements relating to the development of antibody-based bio therapeutics pharmaceutical development processes
• Problem-solving and decision-making skills, as well as the ability to prioritize and successfully manage complex and competing projects
• Ability to travel up to 25%
Source: Job Diva – Job Listing