Purpose

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution of clinical trials, post market vigilance and post market studies, assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs.

Associate Director, Safety, Medical & Regulatory Quality is part of the R&D Quality Medical Affairs (MA) QA team which provides independent quality oversight of AbbVie’s Medical Affairs and Health Impact (MHI) function and other functions engaged in Real-World Evidence (RWE) generating activities. The role covers AbbVie’s entire portfolio of drug, device and cosmetics. The role ensures quality excellence through successful business partner collaboration and provides expert technical quality support and consultation to R&D colleagues and business partners. May support Regulatory Agency inspections.

The role reports to the Director, Safety, Medical & Regulatory Quality. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large.

Responsibilities:

• Contribute to a state of continuous compliance with global regulations, AbbVie policies and procedures and regulatory preparedness for relevant Regulatory Authority Inspections to deliver business results while positioning AbbVie for future success.
• Develop, support and execute a holistic quality assurance model for regulated Medical Affairs and RWE generating activities, inclusive of internal and vendor performed activities and ensure integration with interfacing business functions
• Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset, risk-based thinking and people leadership to support innovation whilst maintaining high levels of compliance.
• Fulfil expectations and goals to ensure organizational success. Embody a culture of open and honest communication where all are encouraged to express their views, offer suggestions and experiment for improvement.
• Lead and contribute to the delivery of innovative quality strategies and solutions through influence and collaboration with MHI and other interfacing functions to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings.
• Determine and evaluate risks impacting compliance with regulated activities and propose and support the implementation of suitable mitigations.
• Support business process owners directly to ensure quality is integrated at all stages of process development.
• Actively participate in front and/or back-room Regulatory Authority inspection activities to enable successful inspections.
• A recognized partner for consultation regarding worldwide regulations and corporate policies, especially for CAPA and associated Quality disciplines.
• Generate, analyze and report metrics to demonstrate key aspects of compliance status, escalating issues in a timely manner for earliest resolution and ensuring the value of QA is recognized and acknowledged.
• Contribute to the development and implementation of systems and processes required to support implementation of global QA strategies. Contribute with applicable R&D Quality business functions to provide support, input and consultation to ensure an inclusive and effective R&D audit program.
• Drive necessary change and efficiency through the provision of effective feedback and recommendations; persists in pursuing and achieving organizational goals and objectives.
• Create an impact by modeling the AbbVie Behaviors in a consistent and visible manner in the conduct of all responsibilities

This role can be remote within the US.