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. MAJOR 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 a scientific background such as 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 pharmaceuticals, medical devices, and combination products Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820, and 211) (preferred) Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures (preferred) Strong written and verbal communication skills Strong organizational skills Knowledge and application of computer systems for word processing and complaint management Ability to work with cross-functional teams and interact effectively with peers, management, and customers
At AbbVie, we are committed to cultivating a workplace culture that promotes inclusion, diversity, and personal growth. We recognize that our collective success is based on the individual well-being of our employees, which is why we have designed a benefits package that considers every aspect of their lives. Enhanced Health and Wellness Coverage: Our administrative staff enjoys comprehensive medical and dental insurance, ensuring peace of mind for you and your loved ones. Extended Vacation: We believe in the balance between work and personal life for our administrative team. That’s why we offer additional vacation days, beyond legal requirements. Flexible Hybrid Work Model: For eligible positions within our administrative staff, we have adopted a hybrid work scheme allowing the convenience of working from home two days a week. Life Insurance: Secure your family’s future with our life insurance policy. Employee Assistance Program (EAP): Access professional support with our comprehensive EAP, offering psychological, legal, and financial counseling. On-Site Health Services: Benefit from the convenience of having a company doctor and physical therapy services, demonstrating our commitment to your health and well-being. Community and Social Engagement: Make a difference with a paid volunteer day, allowing you to contribute to the community during company working hours. Special Leave Benefits: Celebrate your life achievements with extra leave days for marriage and enjoy your birthday with a day off. Employee Stock Purchase Plan: Participate in our company's success by purchasing shares at a special price exclusive to employees. Transportation and Meals subsidized. Solidary Association: Join a community focused on mutual help and enjoy the benefits that come with being a member. A