The quality specialists in US Commercial are responsible for providing quality assurance support for commercialized pharmaceutical products, medical devices, combination products, and biologics, as well as the support of the quality system elements that apply to the US Commercial business. Specific areas of support may include supplier management and monitoring, CAPA, and Management Review. This position will ensure that all product, process, or system-related quality activities are in compliance with Corporate and government regulations. This role must understand and promote compliance with the US FDA CFR regulatory requirements for the Prescription Drug Marketing Act (PDMA), Good Distribution Practices (GDP), Advertising and Promotional Material, as well as AbbVie policies and procedures. Manage and report PDMA events to the FDA per requirements, and manage associated documentation, tracking, follow-up activities, and metrics. US Commercial Quality works collaboratively with Sample Operations, vendors, Medical Review, Regulatory, Commercial Operations, OEC, Legal, and other cross-functional areas.
· Assist in the design of effective quality systems, procedures, and/or processes within cross-functional teams to ensure compliance as well as efficiency throughout our quality system.
· Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
· Participate in training and education programs for various aspects of quality assurance.
· Report and track PDMA events, associated activities, and exception reports to closure.
· Develop, report, and analyze key metrics related to PDMA, including Management Review metrics.
· Supplier management and monitoring to ensure quality performance expectations are met for key PDMA vendors.
· Support internal and external PDMA-related audits as necessary.
· Enter and manage PDMA related exception reports in the quality management system (SolTRAQs), and work with other areas involved to complete the reports and any associated Corrective and Preventive Actions (CAPA).
· Support advertising and promotional Material Review Board (MRB) investigations and other activities.
· Perform random audits of field sales sampling activities.
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
- 5+ years’ experience in quality assurance, quality oversight or relevant experience.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
- Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
- Strong oral (with all levels of management) and written communication skills needed.
- Excellent interpersonal skills a plus.
- Runs and manages small to medium sized quality related projects.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.