AbbVie
Associate Director, Medical Affairs Quality Assurance
AbbVie, North Chicago, Illinois, us, 60086
Overview
Associate Director, Medical Affairs Quality Assurance – AbbVie This role is remote within the US and reports to the Director, Safety, Medical & Regulatory Quality. The position expects leadership aligned with AbbVie’s Ways We Work and a strong focus on quality oversight across Medical Affairs and Real-World Evidence activities. Responsibilities
Contribute to continuous compliance with global regulations and AbbVie policies to ensure regulatory preparedness for inspections and accurate business outcomes. Develop, support and execute a holistic quality assurance model for regulated Medical Affairs and RWE activities, including internal and vendor-led work, with integration to interfacing functions. Demonstrate AbbVie Leadership Attributes, apply risk-based thinking, and lead cross-functional collaboration to maintain high compliance while enabling innovation. Lead and deliver innovative quality strategies and solutions in collaboration with MHI and other functions to address compliance issues and inspection findings. Assess and mitigate risks impacting regulated activities and support implementation of appropriate mitigations. Support process owners to ensure quality is integrated throughout process development. Participate in Regulatory Authority inspection activities when needed to ensure successful inspections. Serve as a trusted partner on worldwide regulations and corporate policies, especially for CAPA and related quality disciplines. Generate, analyze and report metrics to monitor compliance status and escalate issues for timely resolution. Contribute to development and implementation of systems and processes to support global QA strategies and an inclusive R&D audit program. Advance organizational goals through effective feedback and continuous improvement. Model AbbVie Behaviors consistently in all responsibilities. Qualifications
Bachelor's degree in Biology, Nursing, Pharmacy, or other science-based field. 5 years of experience in Medical Affairs, RWE generation, epidemiology, and/or quality assurance in the pharmaceutical industry. 5 years of experience in Quality Assurance. Strong analytical skills and ability to organize work logically; experience interacting with R&D Quality partners and external collaborators. Extensive knowledge of quality standards and worldwide regulatory requirements related to Medical Affairs and RWE activities. Ability to adapt to changing assignments, prioritize with minimal supervision, and work in fast-paced environments. Project management, interpersonal, and communication skills with the ability to influence at all levels. Ability to work independently or as part of a team and communicate effectively. Base Pay
Base pay range: $137,500.00/yr - $261,000.00/yr Additional Information
Compensation range is subject to geographic location and is disclosed where required by law; actual pay may differ based on candidate qualifications and location. AbbVie offers a comprehensive benefits package and eligibility for short- and long-term incentive programs where permitted by law. AbbVie is an equal opportunity employer. See AbbVie’s Equal Employment Opportunity statement for details. Note: No information herein constitutes a promise of employment or compensation unless formally agreed upon in a written agreement. US & Puerto Rico applicants seeking accommodations can learn more here: https://www.abbvie.com/join-us/reasonable-accommodations.html
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Associate Director, Medical Affairs Quality Assurance – AbbVie This role is remote within the US and reports to the Director, Safety, Medical & Regulatory Quality. The position expects leadership aligned with AbbVie’s Ways We Work and a strong focus on quality oversight across Medical Affairs and Real-World Evidence activities. Responsibilities
Contribute to continuous compliance with global regulations and AbbVie policies to ensure regulatory preparedness for inspections and accurate business outcomes. Develop, support and execute a holistic quality assurance model for regulated Medical Affairs and RWE activities, including internal and vendor-led work, with integration to interfacing functions. Demonstrate AbbVie Leadership Attributes, apply risk-based thinking, and lead cross-functional collaboration to maintain high compliance while enabling innovation. Lead and deliver innovative quality strategies and solutions in collaboration with MHI and other functions to address compliance issues and inspection findings. Assess and mitigate risks impacting regulated activities and support implementation of appropriate mitigations. Support process owners to ensure quality is integrated throughout process development. Participate in Regulatory Authority inspection activities when needed to ensure successful inspections. Serve as a trusted partner on worldwide regulations and corporate policies, especially for CAPA and related quality disciplines. Generate, analyze and report metrics to monitor compliance status and escalate issues for timely resolution. Contribute to development and implementation of systems and processes to support global QA strategies and an inclusive R&D audit program. Advance organizational goals through effective feedback and continuous improvement. Model AbbVie Behaviors consistently in all responsibilities. Qualifications
Bachelor's degree in Biology, Nursing, Pharmacy, or other science-based field. 5 years of experience in Medical Affairs, RWE generation, epidemiology, and/or quality assurance in the pharmaceutical industry. 5 years of experience in Quality Assurance. Strong analytical skills and ability to organize work logically; experience interacting with R&D Quality partners and external collaborators. Extensive knowledge of quality standards and worldwide regulatory requirements related to Medical Affairs and RWE activities. Ability to adapt to changing assignments, prioritize with minimal supervision, and work in fast-paced environments. Project management, interpersonal, and communication skills with the ability to influence at all levels. Ability to work independently or as part of a team and communicate effectively. Base Pay
Base pay range: $137,500.00/yr - $261,000.00/yr Additional Information
Compensation range is subject to geographic location and is disclosed where required by law; actual pay may differ based on candidate qualifications and location. AbbVie offers a comprehensive benefits package and eligibility for short- and long-term incentive programs where permitted by law. AbbVie is an equal opportunity employer. See AbbVie’s Equal Employment Opportunity statement for details. Note: No information herein constitutes a promise of employment or compensation unless formally agreed upon in a written agreement. US & Puerto Rico applicants seeking accommodations can learn more here: https://www.abbvie.com/join-us/reasonable-accommodations.html
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