Senior QA Specialist

The Commercial Quality Specialist is responsible for independently providing Commercial Quality support in the affiliate.  Scope of activities includes quality system requirements associated with:  pharmaceutical products medical devices combination products biologics and cosmetics.  Specific areas of support may include Storage and Distribution potential quality events/product shortage Supplier Controls Product Quality Review Risk Management Agency inspections/internal audits CAPA and overall Quality Manual requirements.  The Sr. Specialist has an in depth knowledge of one or more elements and is considered a subject matter expert in these areas.  This position will ensure that all product process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate governmental and local regulations and requirements.    

• Responsible for the integration of local quality regulations for biologics device 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 to 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 the Management Review process for the affiliate. 

Represent Commercial Quality in cross functional teams projects and programs as assigned by management

Qualifications :

• Bachelors Degree in Chemistry Pharmacy Biology Microbiology Engineering or other technical/scientific area preferred. 
• 3 years experience in quality assurance GMP or GDP environment preferred. 
• Strong computer skills 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 an indepth 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. 
• Make decisions in collaboration with management
• Acts as an owner uses available resources to independently complete assigned tasks
• Influencing   Understand your stakeholders and shape communication; can negotiate to win
• Personal Presence Demonstrate the confidence that matches their subject matter expertise and intellectual capacity

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies 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.

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