Manager, APQR Specialist T500-18017
1 day ago
Position SummaryThe Annual Product Review (APQR) Specialist –Serves to support the consistent execution by leading End-to-End (E2E) Annual Product Quality Reviews (APQRs) for all commercial Biologic Marketed Products. The APQR specialist will work collaboratively other Global Biologics Quality, Manufacturing Science and Technology (MS&T) and other Global function team members to ensure timely, E2E, right first-time execution across the Lifecycle of BMS Marketed Products.
Key ResponsibilitiesAs an Individual contributor:The Annual Product Review (APQR) Specialist –Will primarily manage the Global BMS End to End APQR program by leading and generating the E2E APQR for all commercial Biologic Marketed Products.
The APQR specialist will be responsible for the completion of this annual compliance expectation by leading a team of Subject Matter Experts to draft and compete the three-chapter document from draft to final approval and delivery to the key stakeholders in alignment with the prescribed schedule. The QPCM will be responsible for the following defined roles and responsibilities: Responsible to Provide oversight and project management coordination of the E2E Annual Product Quality program by compiling the E2E APQR for assigned commercial brands. Provide in depth quality and compliance oversight during report creation through coordination with APQR Global process owner, QPLs, and Subject Matter Experts (SMEs).
Responsible for ensuring adherence to APQR execution schedule and timelines. Responsible for ensuring all elements of the AQPR procedure are fulfilled. Responsible for facilitating review and approval meetings, problem-solving key issues, and effectively managing communications with key stakeholders.
Responsible for collecting review feedback and resolving comments and questions. Responsible for projecting and communicating stakeholder actions and timing. Responsible to escalate any deficiencies in the draft APQR which cannot be resolved with the working teamResponsible for escalation of risk to not meeting the completion date.
Responsible for providing opportunities for process improvement. Responsible to deliver the APQR to the BMS Canada team to execute the Yearly Biological Product Reports (YBPR)Foster compliance to GMPs and BMS Policies and Procedures. Qualifications & ExperienceSpecific Knowledge, Skills, Abilities:Understanding of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes required.
Experience in a GMP Quality role required Working knowledge of conducting and compiling APQRs Prior experience with navigating multiple Quality Management systems. Demonstrated tactical thinking capability with strong project management skills and ability to focus on execution of strategic decisions.
Ability to work in a matrix environment. Ability to build strong relationships by being transparent, reliable, and delivering on commitments. Effective communication skills.
Ability to provide innovative ideas, align and make decisions balancing speed, quality, and risk. Fluent in English, with proven professional working proficiency in English for reading, writing and speaking. Education:Minimum 8-10 years of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated leadership in Quality Compliance or Operations preferred.
Travel:Must have ability to travel to US required (specifically for training purposes)
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