Complaint Reporting Supervisor

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.

The Complaint Reporting Supervisor works to support Post Market Quality Assurance (PMQA) through providing leadership to the complaint reporting/vigilance specialists. The individual is considered a subject matter expert (SME) for complaint reporting and will serve as a day-to-day resource for the team to support the group. The objective of this function is to ensure compliance with regulatory and corporate requirements, assure product quality and customer satisfaction, and develop and maintain operable quality systems that are cost effective. Individual will work in AbbVie’s global quality organization to report pharmaceutical, medical device and combination product complaints. Interface with internal and external AbbVie customers such as regulatory bodies (i.e. the FDA), 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 the oversight of the creation and submission of regulatory reports, coordination of customer communications and third party interface.

Responsibilities:

• Provide day-to-day direction and leadership for the development and implementation of systems that assure consistent application.
• Lead personnel in the application of Quality Assurance policies, procedures, projects, product launches, systems and serve as the point of contract for the team. May be required to assist with complaint intake based on business needs.
• May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Develop staffing requirements.  Supervise/manage nonexempt employees and ensure training and development plans are current and executed.
• Make independent compliant decisions based on knowledge of regulatory requirements.
• Initiate, manage, and execute projects to continuously improve the overall effectiveness of the department.
• Manage various departmental projects, area metrics, and KPIs.
• Minimize Data Integrity errors within a quality system and assure GMP documentation standards.

Qualifications

Qualifications:

 

• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• 5+ years work experience in cGMP related industry or in a clinical setting.
• 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.
• Project management experience-strong leadership ability, communicate quality requirements effectively and timely.  Runs and manages small to medium sized quality related projects.
• Strong oral and written communication skills (with all levels of management) needed.
• Excellent interpersonal skills a plus.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.