The QA Manager, PDMA is responsible for providing leadership and oversight of Quality Compliance matters in support of quality system requirements associated with sample distribution, Supplier Controls, Risk Management, Agency inspections/internal audits, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business from receipt through shipment of final product are in compliance with corporate, governmental, and local regulations. The QA Manager, PDMA position manages a team of QA Specialists and is responsible for coordinating with applicable US Commercial areas, third party vendors, and internal cross function stakeholders to ensure compliance to AbbVie prescription drug sampling and other free goods programs. Additionally, the Manager is held responsible to monitor and report compliance events per federal and state government requirements, to establish appropriate quality systems, partnering with OEC, Compliance, Legal, and Commercial to assist and drive compliance. The QA Manager, PDMA is also responsible for implementing supplier quality programs. In this capacity, the Manager ensures appropriate quality requirements, agreements, expectations, as well as monitor the supplier audit program. • Manages the US Commercial Operations quality compliance assessment program to ensure regulations set forth in Title 21, Code of Federal Regulation (CFR) 203 are consistently met. • Responsible for the management and oversight of a team, as applicable, including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues. Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs. • Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance. • Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity. • Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward. • Oversee coordination and investigation of key quality systems (ie. CAPA, Management Review, etc.) ensuring KPIs are being met. • Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. • Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans. • Quality management of supplier qualification program including performance monitoring for key suppliers, QTA management and assessments. • Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments for physician sample product. • Oversee and ensure compliance to FDA reporting of PDMA events including significant losses, thefts, falsifications, diversions, and convictions. • Work with Corporate policy team to establish PDMA and product protection policies (counterfeiting, diversion as applicable to pharmaceutical drug samples). • Subject matter expert and representative for US Commercial Operations and is the primary contact during audit, inspection, and assessment by regulatory agencies related to PDMA samples. • Represent QA in regional, global and cross functional teams, projects and programs, as appropriate. • Support the promotional materials process owned by US Sample Compliance as needed.
Bachelors Degree 8+ years of total experience including 3+ years of people management experience 3+ years of distribution and/or quality experience Technical experience in Good Manufacturing Practices and/or Good Distribution Practices. Good written and oral communication skills as well as participation in groups and/or teams. Excellent knowledge of computer systems including Microsoft Word, Excel and PowerPoint Knowledge and understanding of applicable quality assurance policies and procedures Knowledge and understanding of Quality Assurance department role and in the global supply chain process Knowledge and understanding of design and functionality of the automated quality systems Proficient in identifying potential exceptions (Regulatory compliance, Product Quality and Patient Safety) Proficient on Root Cause Analysis and CAPA
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will de