Mgr, Quality Systems and Compliance

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 Quality Systems and Compliance Manager oversees Quality Engineers and Quality Compliance Representatives engaged in activities to support Product Surveillance for all products.

• Responsible for the management, coordination, and evaluation of a team of Quality Engineers and Quality Compliance Representatives.
• Manages project and departmental support with a focus on activities linked to compliance, to ISO certification, FDA compliance and other applicable Regulatory bodies and AbbVie requirements.
• Participates in maintaining quality system documentation including but not limited to: Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs.
• Provides necessary support for product field actions.
• Responsible for Product Surveillance local management review and participates in quality system management review.
• Oversees Global Product Surveillance CAPA program and is responsible for the site's internal audits.
• Oversees internal, supplier and regulatory audits and preparation activities as necessary.
• Engages in activities to support site Supplier Quality activities, Quality Plan initiation and execution and product surveillance global harmonization activities.
• Supports and ensures regulatory compliance activities for Global Product Surveillance.

Qualifications

Education and Experience

• Bachelor's degree (scientific degree preferred) and two to five years related experience and/or training in a regulated industry (Pharmaceutical, Medical Device, Nuclear, etc..) or in a medical environment.
• Supervisory experienced preferred but not required.

Essential Skills, Knowledge and Abilities

• Ability to communicate and collaborate with other departments such as the Device Analysis Lab, Quality Assurance, Regulatory Affairs, Clinical Studies, Customer Care, Operations, and Marketing departments to ensure corporate goals and strategies are met. This includes other facilities such as Costa Rica, Marlow, UK, Irvine, Pringy, France, Branchburg, Madison, and Pleasanton.
• Knowledge of applicable regulations including, but not limited to, 21 CFR 803, 21 CFR 820, 21 CFR 821, 21 CFR 4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016, and other international complaint handling and vigilance regulations.
• Experience in TrackWise and eLMS preferred.
• Set a good example for all employees in performance, attendance, dress, and professionalism.
• Ability to provide accurate and complete information in a prompt manner.
• Ability to read, analyze, and interpret complex documents.
• Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to coordinate and synchronize multiple projects.
• Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities.
• Ability to handle restricted, confidential, private, or personal information in accordance with departmental policies, HIPAA, and related international standards.
• Ability to work with staff and peers and across a matrixed organization.
• Ability to analyze training needs.
• Ability to travel to meetings, audits/inspections, and professional seminars. Ability to drive a car; possess a valid and current driver's license.

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
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.