Program Manager, Qualification and Validation
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 Program Manager, Qualification and Validation, (Q&V) is responsible for managing / driving or participating in global projects to completion, (SOP creation / updates, alignment on strategy, deployment of new systems / technologies etc.). They will participate in monitoring of Q&V regulatory intelligence and development of responses.
- Manage Q & V projects / program, creates SOP's / updates and ensures alignment across global stakeholders.
- Helps provide strategic direction for design and construction of facilities, utilities and equipment through participation on the AbbVie Engineering Standards Committee, SME for Calibration and Preventive Maintenance.
- Participates on Cross Functional Teams and provides Quality review and approval of EFU, Software / APC, Process or Cleaning validation project deliverables when needed to alleviate resource constraints during periods of high validation activity
- Represents team at Regulatory Intelligence meetings - provides feedback and helps to develop and execute the response strategy when an impact to Q&V practices are identified.
- Electronic Validation System SME / Owner
- Run project cross contamination risk assessments and provide input to best practices for qualification risk assessments.
- Lead the qualification teams through their Data Integrity assessments.
- Implement and maintain the global cross-contamination risk assessment Program for R&D.
- 4 year college degree (BS preferred) in the Biological or Physical Sciences, Engineering or Computer Science
- Minimum of 8 years in Quality Assurance or related field, such as a regulated GxP environment - qualification / validation, documentation or compliance
- Demonstrated ability to lead multi-cultural, multi-functional teams and to work in a complex and matrix environment
- Ability to make critical, creative and strategic decisions as a result of rapid analysis of available information. Must be able to respond quickly to unplanned events and changing needs while balancing speed, quality and risk to the patient and for the business.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
Job Level Code
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.