Senior RDQA Quality Lead - Global Clinical Trials

AbbVie; North Chicago (IL); Hybrid; USD 140,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k)

Job summary

AbbVie is seeking a Senior Manager, RDQA AREA, to lead quality assurance across US Affiliates. The role focuses on proactive quality management, collaboration with RDQA and Affiliate leaders, and achieving first-pass approvals through robust risk-based strategies.

Responsibilities include governance of quality systems, audits, and inspections readiness in a complex regulatory landscape, with travel up to 35% and leadership of regional initiatives.

Qualifications

• Bachelor's degree in Biology, Nursing, Pharmacy or related medical science field.
• 8+ years biopharmaceutical/medical device quality, regulatory affairs, or clinical research experience.
• 3+ years in leadership positions.
• Strong knowledge of local and global regulatory requirements.
• Excellent communication and problem-solving skills.

Responsibilities

• Provide support for the assigned countries and region.
• Implement and execute proactive quality management activities.
• Maintain collaborative relationships with RDQA functions in Affiliates.
• Drive quality excellence and achieve first-pass approvals with health authorities.
• Oversee quality and compliance in a regulated environment.
• Develop risk identification and mitigation strategies for clinical research.

Skills

Analytical skills

Communication skills

Leadership experience

Travel up to 35%

Education

Bachelor's degree in Biology/Nursing/Pharmacy or related field

8+ years biopharma/medical device quality/regulatory experience

Job description

AbbVie is seeking a Senior Manager, RDQA AREA, to lead quality assurance across US Affiliates. The role focuses on proactive quality management, collaboration with RDQA and Affiliate leaders, and achieving first-pass approvals through robust risk-based strategies.

Responsibilities include governance of quality systems, audits, and inspections readiness in a complex regulatory landscape, with travel up to 35% and leadership of regional initiatives.