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. Purpose: Primarily responsible for developing, negotiating, and writing new and revised quality agreements and supporting agreements for global R&D and Operations (with R&D involvement) as needed. Responsibilities: Manage processes for the timely QA writing / review / approval of Quality Agreement related policies, processes, procedures, templates, and other documentation Identify, lead / facilitate process improvement and efficiency projects pertaining to GxP Compliance within R&D and between R&D and Operations and / or Third Parties including interpretation, explanation and application of the applicable current regulations, guidelines, policies, and procedures AbbVie R&D Quality Agreement liaison with Operations including negotiating / writing R&D elements for shared R&D / Operations Quality Agreements and associated documents Manage Quality Agreement life cycle; lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Quality Agreements, as applicable Collect, analyze, and report metrics pertaining to GxP Compliance Support audit activities with respect to Quality Agreements and other Quality System elements including audit preparation, responding to audit requests, subject matter expert resource Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approve if adequate Review/edit GxP Service Provider business contracts/agreements and related documents for Quality related subject matter to ensure compliance with current regulations/guidance/industry standards and AbbVie Quality System requirements. Qualifications Bachelor’s degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required 8+ years’ experience in Quality Assurance or related field 5-7 years’ Experience in Quality Assurance / Regulatory Affairs (Pharmaceutical preferred) 3-5 years’ Clinical Research Development / Manufacturing, finishing or analysis of investigational drug supplies Minimum of 7 years’ total combined experience required (Not necessarily the sum of the above) Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements. Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgment and the ability to make difficult decisions, often at short notice. 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.