Manager, Quality Systems

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:

The purpose of this role is to support Safety Compliance leadership to develop, implement, maintain and monitor an optimized Quality Management System for the Pharmacovigilance and Patient Safety (PPS) organization that at a minimum meets global regulatory legal requirements and standards, and additionally promotes best practice and excellence. The scope extends to Pharmacovigilance (PV) activities worldwide and spans the life cycle of all products. This role is primarily responsible for PV documentation, training and compliance monitoring.

Responsibilities:

• Independently resolves routine issues. Handles complex problems with proposing potential solutions to management. Contributes to departmental policy.
• Responsible for the maintenance and continuous improvement of the PSMF.
• Reviews, develops and monitors global Pharmacovigilance compliance metrics.
• Organize quality control plans, global internal Pharmacovigilance audit and external regulatory inspections, responses to audits and inspections (e.g., FDA responses), and resulting improvement plans.
• Recognizes, evaluates, develops and implements global process improvements in GPV quality systems.
• Authors compliance documents (e.g., training matrix, CAPA).
• Administers comprehensive GPV quality system.
• Reviews, evaluates and proposes necessary changes to regulatory guidance (e.g., ICH).
• Manages internal and external global audit process, responses and develops associated improvement plans (e.g., EU audits, FDA meetings; responses to warning letters).
• Evaluates and develops appropriate work tools and methodologies to enable staff to continually improve performance and productivity.

Qualifications

• Bachelor’s degree with related health science or quality background. Advanced degree preferred.
• Minimum 5 years pharmaceutical experience; 1-3 years should be quality and management experience.
• Job Grades are determined by the country in which the payroll is based

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
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.