Global Complaints Senior Manager

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose:

Individual will lead the Global Complaint team which processes medical device 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.
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Qualifications

Qualifications:

•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.
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Significant Work Activities
N/A
Travel
Yes, 25 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.