The Senior Manager, Biologics External Manufacturing Quality (EMQ) serves as a Product Quality (PQ) 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 Company requirements. This role participates in the resolution of CMO operational issues, maintains an effective working relationship with CMOs and internal team members, tracks quality related issues, and participates in CMO business meetings as required.
This position works with Tech Ops, PM CFU, 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 the Company . 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.
Assess suitability of cell banks, bulk drug substance, and packaged / labeled drug product for further processing and eventual use in clinical and commercial product
Ensure CMO compliance to international GMP regulations as well as Company expectations including trending and evaluation of issues for impact to product on a continual basis as well as external audit support
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
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
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.
BS/BA (required) in the pertinent life sciences or engineering; advanced degree desirable.
8+ years of Quality experience in a GLP, GMP and/or ICH/GCP environment required.
5+ years biologic industry experience strongly preferred.
Experience managing external manufacturing providers and partners is required.
Knowledge of GMP manufacturing processes (Biologics/drug) including Drug Substance and Drug Product is required
Knowledge and experience with all aspects of Quality System Management, lot disposition, deviation and investigations, change management, complaints, CMC participation, training, preparing/reviewing Annual Product Reviews, and auditing
Thorough working knowledge of regulated GMP systems as well as FDA, EMEA, ICH and JP regulations
Experience with requirements relating to the development of antibody-based bio therapeutics pharmaceutical development processes
Strong working knowledge and understanding of validation principles, tech transfer and product lifecycle
Knowledge of aseptic manufacturing processes, experience with cell culture and purification. Process characterization and validation experience is desirable.
Proficient in Microsoft Office tools.
Problem-solving and decision-making skills, as well as the ability to prioritize and successfully manage complex and competing projects.
Excellent communication skills - verbal and written.
Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations.
Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
Flexible in working with associates from all departments and organizational levels, including external partners, while meeting commitments.
Values consistent with Company Values (Integrity, Respect, Professionalism, Quality and Teamwork); together with an intrinsic understanding of Company’s hhc Mission and the need to always think first of the Patient.
Ability to travel up to 25% (domestic and international)