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. Responsibilities: Manages completion of all CAPA/exception reporting for the clinical supplies manufacturing, packaging, shipping, and warehousing groups. Includes investigating events, assessing impact to product, and developing/implementing corrective actions for future batches. Ensures all CAPA activities are completed with timeliness required to meet clinical product release requirements as well as compliance timeliness requirements. Serves as the primary clinical drug supply management site contact for all audits of the facility. Interface directly with the auditors throughout the audit process. Leads the cleaning validation/verification program for the drug product pilot plant. Creates and maintains quality procedures, GMP training modules, and GMP job descriptions for the clinical manufacturing groups. Develop and implement practices and procedures that provide appropriate and efficient compliance to regulatory and AbbVie requirements. Manages change management activities for drug product pilot. Manages a group of up to five personnel. Participates in the hiring, training, and development of group members. Carries out day-to-day supervisory duties (work scheduling, project assignments, performance reviews, growth plans, etc.) towards achievement of center & project goals. Qualifications Basic: Experience in a compliance management role is preferred. PhD or equivalent + 6 years in a science related field or equivalent, MS or equivalent + 8-10 years of experince, BS or equivalent + 10-12 years of experince. QA experience desired. Scientific compliance knowledge and experience. Leadership experience preferred. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No 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.