Sr Mgr, Post Market Quality

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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.

• Bachelor’s Degree required; preferably in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN).
• 8+ years of work experience in a cGMP related industry or in a clinical setting (preferred)
• 4 years of management experience preferred.
• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
• Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
• Solid written/verbal communication and organizational skills.
• Knowledge and application of computer systems for word processing and complaint management.
• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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