Associate Director, Medical Affairs Quality Assurance

Role Summary

Associate Director, Medical Affairs Quality Assurance is part of the R&D Quality Medical Affairs (MA) QA team, providing independent quality oversight of AbbVie’s Medical Affairs and Health Impact (MHI) function and other Real-World Evidence (RWE) activities. The role covers AbbVie’s entire portfolio of drug, device and cosmetics, and ensures quality excellence through collaboration with business partners. The position may support Regulatory Agency inspections. Location: Remote within the US.

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 AbbViе Behaviors in the consistent and visible conduct of all responsibilities

Qualifications

• 5 years of experience in Medical Affairs, RWE generation, epidemiology, and/or quality assurance supporting those areas, preferably in the pharmaceutical industry.
• 5 years of experience in Quality Assurance.
• Strong analytical skills and the ability to organize work in a logical, thorough, and succinct manner. Ability to work and interact with R&D Quality business partners and external partners.
• Extensive knowledge of quality standards, worldwide regulatory requirements and industry best practices relating to Medical Affairs and RWE generating activities.
• Flexibility to adapt to changing assignments and ability to effectively prioritize with minimal supervision. Ability to work in a fast-paced, high pressure and changing environment in an autonomous manner.
• Project management, interpersonal, and communication skills with ability to influence at all levels.
• Comfortable working independently or as part of a team.
• Strong communication and interpersonal skills

Education

• Bachelor's degree preferably in Biology, Nursing, Pharmacy, or other science-based degree.