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 Supports the interpretation and application of GCP and regulatory principles (EU MDR, ISO 14155, CFR 812, ICH E6 R2, FDA 21 Part 11) into action in support of Development and business partners to drive execution of high quality clinical trial conduct with minimal supervision. Leads issue management activities for business partners demonstrating excellence in the identification, assessment and delivery of documentation of potential non-conformities, non-conformities, and oversight of effectivity checks with limited managerial oversight. Demonstrates high degree of competence in delivering effective issue escalation and business continuity meetings. Responsibilities Partners with BPO, Functional and Development Leaders to support delivery of program, business process and functional compliance-related deliverables with minimal management oversight. Partner with peers to share best practices and to align in delivery of strategic objectives. Able to translates the vision, mission, and operational tactics of Clinical Compliance and apply them to functional deliverables, including but not limited to issue capture, assessment and documentation. Oversees compliance metrics for assigned BPO and Function, and delivers on-time and comprehensive compliance metrics to support functional activities and overarching compliance metrics for Sr Leadership and business partners. Using expertise to providing interpretation of possible signals or trends. Drive meetings and discussions, managing delivery of actions to closure, and general oversight of the business continuity plan for Development Operations as it impacts areas or BPOs supported with minimal managerial oversight. Represents Clinical Compliance in various initiatives within Development Operations or drives initiatives within Clinical Compliance. Apply and lead discussions with business partners regarding application of Quality Manual principles in support of the ways we work. Effectively manages, prioritizes and balances work activities for areas supported to effectively utilize resources to ensure business needs are met. Reviews new and revised regulations, determining and interpreting content and implications with business partners to assess impact to clinical trial conduct and associated processes. Drives discussions with business partners relative during procedural or process changes to ensure regulatory requirements are understood and maintained. Delivers Development inspection support provided by Clinical Compliance (inspection support, response review and coordination, evidence review) with minimal oversight Qualifications Education Requirements BS or BA required; advanced degree preferred Quality certification a plus Required Experience 6 +yrs experience in Pharma, Device or Related Field (e.g. Compliance or Quality leader) Medical Device/Digital Health Tool experience preferred Versed in EU MDR, ISO 14155, CFR 812, ICH E6 R2, and FDA 21 Part 11 preferred Demonstrates analytical and critical thinking skills. Possesses good communication skills and demonstrated leadership abilities and problem solving skills. Able to translate strategy into operations and manage multiple changing priorities. Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance). Mgt / Supervisor Demonstrates successful coaching or leadership of matrixed team Candidate Profile Experienced and knowledgeable in medical devices/digital health tool and EU MDR, ISO 14155, CFR 812, ICH E6 R2, and FDA 21 Part 11 Adept at managing multiple priorities Able to translate quality and compliance topics into strategic actions Informal influencer Competent in Stakeholder Mgt Knowledge of the business Manages conflict with successful outcomes Shows grace under pressure Sought as resource and partner by business partners Competent in issue management/CAPA and risk assessment and mitigation New to role or requires minimal oversight Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) 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.