QA Validation Manager

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 .

• Responsible for the audit, pre-approval, and post-approval of all process validation protocols, cleaning protocols, and analytical test method protocol as the QA signature.
• Maintain and control the Validation Change Control Program for the validated/qualified systems and the Validation Management System (VMS).
• Review and approval of Validation Master Plan.
• Create validation documents, such as Soltraqs Change Plans, Validation Plans, Technical Reports, and Position Papers.
• SME on process validation aspects (process changes, cleaning validation, dust controls, hold times, test method validation, analytical instrumentation qualification).
• Conduct training related to Validation, Qualification, and Management of change.
• Responsible for all validation aspects of new product introduction, validation lifecycle management
• Accountable to drive continuous improvement to the validation processes by developing and supporting projects to streamline processes from unnecessary tasks and paperwork.
• Provide leadership and guidance for validation related CAPA activities.
• Member of the Quality Risk Management and participate in the development of FMEAs and Risk Control Plans as validation SME.
• Administer the Validation Review Board.

Qualifications

• Bachelor Degree in Sciences (Chemistry, Biology, Microbiology, Engineering or other technical/scientific area.
• Eight (8) years minimum of experience in quality assurance or related field handling validated/qualified systems on a regulated industry.
• High degree of initiative, decision-making, and responsibility which would enablehim/her to perform efficiently with a minimum of supervision.
• Exposure to FDA/DEA regulations and inspection.
• Excellent interpersonal relationships with subordinates, peers, and supervisors
• Must be fluent in Spanish and English, both verbal and written.

Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 10 % of the Time
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.