R&D Sr. Quality Officer
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.
Role supports the quality oversight of the R&D laboratory function associated with GMP testing for biological and small molecule projects. Quality assurance reviewer/approver of documentation generated in the laboratory area such as protocols, reports, investigations and assessments.
• Performs quality assurance review and approval of analytical method validation and transfer documentation.
• Investigates and resolves laboratory investigations. Performs the quality assurance review and approval of laboratory investigation reports, including out-of-specification reports, incident reports and non-conformances for both internal and CRO laboratories. Determines if corrective and preventative actions are adequate and evaluates the impact on materials.
• Performs quality assurance review and approval of analytical procedures for compliance with company policies, ICH and regional requirements.
• Performs quality assurance review and approval of stability protocols/reports and expiry justifications.
• Conducts review of documentation related to reference standard use and qualification.
• Gathers information such as compliance history of investigations and incidents for external laboratories towards supplier management assessments.
• Reviews and approves laboratory technical assessments.
• As the quality representative on R&D project teams, provides guidance to the team members for quality matters based on company procedures and consult with management when necessary. Responsible for the quality-related project tasks, which are carried out independently or via coordination with the SME colleague in the quality department.
• Contributes to the overall functioning of the department including other quality assurance activities delegated by the Manager.
• Training and experience equivalent to Bachelor’s degree in general science with an emphasis in chemistry, biology or microbiology
• At least seven years of industry experience in GMP laboratory practices and quality assurance
• Knowledge of principles of analytical method validation
• Knowledge of regulatory guidances related to laboratory investigations
• Interpreting multiple standards and applying them to department activities
• Detail oriented with proven organizational skills
• Handling a wide variety of tasks under time constraints
• Interpreting and evaluating data and summarizing results
• Excellent interpersonal skills with team player orientation
• Strong computer skills, especially within a Microsoft Windows® operating system
Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
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.