Energy Jobline ZR
Director, QA R&D - PV Audits in North Chicago
Energy Jobline ZR, North Chicago, Illinois, us, 60086
Overview
The Director of Pharmacovigilance Auditing at AbbVie is responsible for implementing a comprehensive audit program and leading a high‑performing audit team to ensure the company’s Pharmacovigilance (PV) system has proper quality, integrity, and controls through strategic audit oversight.
Responsibilities
Lead collaboration across R&D Quality, Safety, and core PV System stakeholders to characterize the audit landscape and routinely assess risks for compliance and quality.
Drive cross‑discipline projects and implement strategies that strengthen the PV system quality foundation and expand the audit team’s capabilities using data and advanced technology.
Monitor new regulations and industry trends; ensure compliance with AbbVie policies and applicable worldwide regulations.
Manage operational and strategic audit issues with appropriate governance and escalation strategies.
Maintain and curate inspection‑ready documentation (SOPs and evidence of execution) to support health authority interactions.
Provide timely data and information to support the Product Safety Master File and ensure audit‑related data accuracy.
Interact with stakeholder leadership to communicate audit targets, improvement areas, and program performance.
Apply risk management practices tailored to audit programs and collaborate with R&D Quality, Compliance, and External Partnership leaders for continuous improvement.
Build a high‑performing audit team, identify and mitigate risks, and enhance the audit function’s success during external audits and inspections.
Improve audit organization connections and utilization of critical Quality System Elements, including Risk Management, Change Management, and Exception Management.
Engage stakeholders in ongoing reviews of audit performance and promote proactive quality activities.
Recruit, develop, and manage a team of quality professionals; define goals, conduct annual performance reviews, and recommend hiring, promotion, or disciplinary actions.
Qualifications
Bachelor’s degree in a physical science, life science, nursing, pharmacy, or equivalent experience.
10+ years of experience in the pharmaceutical industry.
Pharmacovigilance experience.
3+ years of people‑leader experience with strong team management skills.
Ability to mentor, coach, and develop high‑performing audit professionals and teams.
Strong decision‑making skills and a proven capacity to balance adaptability with timely execution.
Expertise in leading, prioritizing, and resource‑planning complex quality improvement projects.
Change‑ready mindset and ability to cultivate trust and accountability within a strategic quality environment.
Location and Compensation The role can be remote within the US or UK. Compensation will be adjusted to the employee’s country of residence and includes a range of base pay, short‑term and long‑term incentive programs, as well as a comprehensive benefits package (vacation, holidays, sick leave, medical/dental/vision insurance, and 401(k) eligibility).
Equal Opportunity Statement AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, and serving our community. AbbVie is an Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join/us/reasonable-accommodations.html
#J-18808-Ljbffr
Responsibilities
Lead collaboration across R&D Quality, Safety, and core PV System stakeholders to characterize the audit landscape and routinely assess risks for compliance and quality.
Drive cross‑discipline projects and implement strategies that strengthen the PV system quality foundation and expand the audit team’s capabilities using data and advanced technology.
Monitor new regulations and industry trends; ensure compliance with AbbVie policies and applicable worldwide regulations.
Manage operational and strategic audit issues with appropriate governance and escalation strategies.
Maintain and curate inspection‑ready documentation (SOPs and evidence of execution) to support health authority interactions.
Provide timely data and information to support the Product Safety Master File and ensure audit‑related data accuracy.
Interact with stakeholder leadership to communicate audit targets, improvement areas, and program performance.
Apply risk management practices tailored to audit programs and collaborate with R&D Quality, Compliance, and External Partnership leaders for continuous improvement.
Build a high‑performing audit team, identify and mitigate risks, and enhance the audit function’s success during external audits and inspections.
Improve audit organization connections and utilization of critical Quality System Elements, including Risk Management, Change Management, and Exception Management.
Engage stakeholders in ongoing reviews of audit performance and promote proactive quality activities.
Recruit, develop, and manage a team of quality professionals; define goals, conduct annual performance reviews, and recommend hiring, promotion, or disciplinary actions.
Qualifications
Bachelor’s degree in a physical science, life science, nursing, pharmacy, or equivalent experience.
10+ years of experience in the pharmaceutical industry.
Pharmacovigilance experience.
3+ years of people‑leader experience with strong team management skills.
Ability to mentor, coach, and develop high‑performing audit professionals and teams.
Strong decision‑making skills and a proven capacity to balance adaptability with timely execution.
Expertise in leading, prioritizing, and resource‑planning complex quality improvement projects.
Change‑ready mindset and ability to cultivate trust and accountability within a strategic quality environment.
Location and Compensation The role can be remote within the US or UK. Compensation will be adjusted to the employee’s country of residence and includes a range of base pay, short‑term and long‑term incentive programs, as well as a comprehensive benefits package (vacation, holidays, sick leave, medical/dental/vision insurance, and 401(k) eligibility).
Equal Opportunity Statement AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, and serving our community. AbbVie is an Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join/us/reasonable-accommodations.html
#J-18808-Ljbffr