Senior Clinical QA Lead, Global Quality and Compliance

Regulatory Jobs; Chicago (IL); Hybride; USD 150 000 - 185 000; Plein temps

Avantages offerts par ce poste

Paid time off

Insurance (medical/dental/vision)

401(k) plan

Long-term incentive programs

Résumé du poste

AbbVie seeks an experienced RDQA professional to lead quality assurance across regions, ensuring regulatory compliance and ongoing inspection readiness. You will partner with clinical development teams to uphold the AbbVie Quality System and drive continuous improvement in quality management.

The role reports to the RDQA leadership and requires up to 35% travel. Hybrid work arrangements across US sites are supported, with a focus on proactive risk management and cross-functional leadership.

Qualifications

• Bachelor's degree required, preferably in Biology, Nursing, Pharmacy or another medical science, combined with equivalent technical experience.
• 8+ years of biopharmaceutical or medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or related development functions, including 3 years in leadership positions (people and/or initiatives/projects).
• Strong understanding of local and global regulatory and legal requirements and of regulatory agency perspectives.
• Thorough knowledge of quality systems, auditing standards and quality management.
• Strong analytical, communication, presentation, negotiation and influencing skills.
• Ability to foster cross-functional collaboration at both global and local levels.
• Additional languages desirable but not required.
• Ability to travel as needed in AREA (up to 35%).

Responsabilités

• Support the assigned countries and region, and implement and execute proactive quality management activities.
• Maintain a close, collaborative relationship with RDQA functions impacting clinical research within designated Affiliates.
• Build working relationships with clinical development leaders and staff to advance the AbbVie Quality System, drive quality excellence, and achieve first pass approval for market authorization by health authorities.
• Oversee quality and compliance in a regulated environment, including AbbVie policies and procedures and country and regional standards and regulations.
• Lead and/or collaborate on risk identification and mitigation strategies for clinical research activities, including clinical trials, with periodic reviews of quality and compliance data.
• Establish quality measures and drive quality strategy in designated countries and region.
• Manage governance and oversight in relation to the One AbbVie Quality System. Identify trends, root causes and potential risks, and drive a continuous state of regulatory preparedness.
• Ensure a consistent understanding of quality requirements for clinical research within Affiliates.
• Maintain awareness of applicable regulations and develop standards to measure quality.
• Support supplier visits, audits and vendor qualifications.
• Develop inspection strategy and provide inspection-readiness support for local and regional Health Authority inspections. Provide oversight, support and follow-up, including inspection report responses, and participate in inspections as needed.
• Determine the need for country and process assessments or audits in collaboration with Clinical Audit and Clinical PM.
• Conduct audits, communicate results, and review and approve corrective action plans and audit responses.
• Support robust audit and inspection responses through coaching and education.
• Mentor AREA Managers and AREA Associates, or take on line management.

Connaissances

Quality Assurance

Regulatory Compliance

Auditing

Leadership

Formation

Bachelor's degree in biology/medical science

Description du poste

AbbVie seeks an experienced RDQA professional to lead quality assurance across regions, ensuring regulatory compliance and ongoing inspection readiness. You will partner with clinical development teams to uphold the AbbVie Quality System and drive continuous improvement in quality management.

The role reports to the RDQA leadership and requires up to 35% travel. Hybrid work arrangements across US sites are supported, with a focus on proactive risk management and cross-functional leadership.