Sr Mgr, Post Market Quality

Purpose: Individual will lead the Global Complaint team which processes medical device or pharmaceutical combination product complaints and inquiries. Will manage complaints from both the Legacy AbbVie and Legacy Allergan portfolios in a global capacity. Interface with internal and external AbbVie customers such as physicians, nurses, pharmacists, hospital personnel, risk managers,  purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and Pharmacovigilance regarding AbbVie product complaints. Responsible for oversight of product complaint documentation, investigations and identification of potential adverse events and potentially reportable events. They will also work closely with the PMQA leadership to help set the direction of the organization.

Responsibilities:

• Provide strategic direction and vision for team located around the world which is responsible for complaint processing. Has a future focused perspective to ensure we are staying ahead of trends.
• Influence the global teams to have an aligned and consistent approach with complaint intake handling.
• Oversee global and US complaint processing methods to ensure complaints related to medical devices, combination products, pharmaceutical and biologics products are appropriately handled, and evaluated.
• Assure complaint records meet global requirements and ensure the team is staying up to date on current obligations.
• Author reply letters to customers addressing the results of complaint investigations. Assure complaint records meet global requirements.
• Identification of potentially reportable events and notification to appropriate functional groups. Lead efforts to resolve.
• Ability to create formal documentation that meets GMP standards and can be used for regulatory filings and/or reporting.  Examples include: Form 3500A and Med Dev.
• Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.
• Oversight of management of a project team or participation on a project team involving process improvements, new product launches, issue resolutions, etc.
• Support leadership in strategy development and continuous improvement activities.