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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

The Opportunity

The Senior QA Associate will work independently to provide quality support for commercial operations in the affiliate. This includes ensuring compliance with quality system requirements for pharmaceutical products, medical devices, combination products, biologics, and cosmetics.

Specific areas of support may include Storage and Distribution, managing potential quality events and product shortages, Supplier Controls, conducting Product Quality Reviews, implementing Risk Management processes, overseeing Agency inspections and internal audits, managing Corrective and Preventive Actions (CAPA), and ensuring compliance with overall Quality Manual requirements.

The Senior QA Associate is expected to have extensive knowledge and expertise in one or more of these areas, making them a subject matter expert. Their role is to ensure that all quality activities related to products, processes, and systems, from the receipt of final product through distribution, comply with Corporate, governmental, and local regulations and requirements.

Cool stuff you get to do;

• Integration of local quality regulations for drugs, biologics, devices, and/or combination products and cosmetics.

• Design effective quality systems, procedures, and/or processes within cross-functional teams to ensure compliance as well as efficiency throughout our quality systems.

• Work on assessments to determine compliance with processes, procedures, and regulations to identify potential gaps and mitigate and implement improvements.

• Plan, prepare, review, and approve quality documentation such as change controls, product reviews, and other local requirements.

• Support internal, external, and MoH audits as directed by the manager, lead self-inspections.

• Coordinate and investigate quality events such as deviations, non-conformances and corresponding action plans including decisions.

• Execute supplier qualification program including performance monitoring for key suppliers.

• Monitor metrics and KPIs to ensure compliance.

• Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

• Support product release for Redressing and Distribution for the local market

• Support the Management Review process for the affiliate.

• Represent Commercial Quality in cross-functional teams, projects, and programs, as assigned by management.

• Qualifications

Experience that will help you get started

• Bachelor’s degree in chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.

• Strong computer skills, and familiarity with SAP, TrackWise, ComplianceWire and OneVault.

• Full understanding of local GxP requirements including regulations and standards affecting device, biologics, pharmaceutical products and cosmetics with in-depth knowledge in one or more areas

• General knowledge and understanding of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations.

• Ability to support projects as a team member or lead as assigned by manager.

• Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.

• Strong written and oral communication skills.

• Good time management skills

• Make decisions in collaboration with management.

• Acts as an owner - uses available resources to independently complete assigned tasks. Influencing - Understand your stake

• holders and shape communication; can negotiate to win.

• Personal Presence - Demonstrate the confidence that matches their subject matter expertise and intellectual capacity.

• AbbVie is an equal-opportunity employer that supports inclusive, flexible, and accessible working arrangements for all. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation or marital status. If you have any support or access requirements, we encourage you to advise us at the time of application. We are committed to creating an inclusive workplace

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.