Senior Manager, Clinical Quality Assurance

GCP Quality Assurance ManagerPrimarily responsible for leading the management of GCP quality activities in support of studies and projects across one or more clinical programs to drive proactive quality management, and ensure compliance with corporate policies and functional procedures and applicable global regulations.As the primary GCP quality interface cross-functionally in R&D for the product, this individual will influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance, assessments as appropriate, design and execution of a "fit for purpose" audit program with the goal of submission-ready quality data, first pass approvals by health authorities for market authorizations, and bringing our compounds to our patients. This is an independent contributor role that will influence across matrix organizations.Responsibilities:Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue ManagementAssess the success and effectiveness of the quality system and assure inspection readiness by designing an audit program of internal and external compliance audits and applicable assessmentsInterpret, explain and apply applicable current governmental regulations, guidelines, policies and procedures to study protocols and associated activitiesPrioritize activities to ensure objectives of studies/programs are metInteract with Development Operations organization and supporting functions to ensure quality compliance across all aspects of clinical development; Identify and mitigate potential clinical quality risks and escalate to management; Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities; Provide project/program leadership in quality as a team member across clinical development functionsAnticipate, influence, and determine present and future business needs in support of quality for a drug development programLead the effort to articulate and present an integrated cross-functional and comprehensive quality strategy planIdentify and implement balanced fit-for-purpose quality management; Develop and recommend strategies and tactics for successIdentify and remove barriers that could impact program objectives, priorities, timelines, and quality. Communicate risks and mitigations to managementServe as the primary program quality liaison during health authority inspectionsQualifications:Bachelor's degree in a physical science, life science, nursing, pharmacy or equivalent experience required5+ years of pharmaceutical industry experience in GCP quality assurance or regulatory affairs or clinical development or clinical operations (oncology-specific a plus, but not a requirement). Prefer 1+ years of GCP QA auditing experienceSuccessful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations.Problem solving abilities required at both strategic and operational levels, ability to identify and resolve issues related to quality and compliance with global and local regulations, polices, and procedures. This involves both internal cross-functional problem solving as well as issue resolution between functional areas and external collaborators.Demonstrated ability in strategic planning and cross functional executionProven track record utilizing core and technical competencies in managing projects in support of clinical researchStrong understanding of global Pharma, clinical development and operations, legal and regulatory environmentsExperience in preparing/presenting key informationComprehensive knowledge of the interrelationship among other RDQA GXP functions and with business functions to serve as a good business partnerAdditional Information:The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.This job is eligible to participate in our long-term incentive programs.AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: Fraud AlertAbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.Protect yourself by verifying job offers and communications. Your safety is important to us.Yes, 10% of the TimePay Range: $124500 - 236500 USDWhere We WorkRole is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role. AbbVie