Senior Manager, Clinical Quality Assurance
AbbVie
August 19, 2026
On-site
North Chicago, IL
$124,500 - $236,500 USD yearly
Clinical Research and Development
Purpose:
Primarily responsible for leading GCP quality activities in support of studies and projects across one or more clinical programs to drive proactive quality management and ensure compliance with corporate policies and functional procedures and applicable global regulations.
Responsibilities:
- Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue Management.
- Assess quality system success/effectiveness and assure inspection readiness by designing an audit program of internal and external compliance audits and applicable assessments.
- Interpret, explain, and apply applicable current governmental regulations, guidelines, policies, and procedures to study protocols and related activities.
- Prioritize activities to ensure study/program objectives are met.
- Interact with Development Operations and supporting functions to ensure quality compliance across clinical development; identify and mitigate clinical quality risks and escalate to management; provide quality leadership across clinical development functions.
- Anticipate and determine present/future business needs in support of quality for a drug development program.
- Lead the articulation and presentation of an integrated cross-functional comprehensive quality strategy plan.
- Identify and implement fit-for-purpose quality management and develop/recommend strategies for success.
- Identify/remove barriers impacting objectives, priorities, timelines, and quality; communicate risks and mitigations to management.
- Serve as primary program quality liaison during health authority inspections.
Qualifications:
- Bachelor’s degree in a physical science, life science, nursing, pharmacy, or equivalent experience (required).
- 5+ years pharmaceutical industry experience in GCP quality assurance, regulatory affairs, clinical development, or clinical operations (oncology a plus; prefer 1+ years GCP QA auditing).
- Progressive leadership experience; strong problem-solving at strategic/operational levels.
- Demonstrated strategic planning and cross-functional execution; track record managing projects supporting clinical research.
- Strong understanding of global Pharma/clinical development/operations and regulatory environments.
- Experience preparing/presenting key information.
- Comprehensive knowledge of interrelationship among RDQA GXP functions and business functions.
Benefits (if applicable per posting):
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for long-term incentive programs.
Location:
North Chicago, IL; Irvine, CA; South San Francisco, CA; Worcester, MA; Dublin, Ireland; Maidenhead, UK.
Primarily responsible for leading GCP quality activities in support of studies and projects across one or more clinical programs to drive proactive quality management and ensure compliance with corporate policies and functional procedures and applicable global regulations.
Responsibilities:
- Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue Management.
- Assess quality system success/effectiveness and assure inspection readiness by designing an audit program of internal and external compliance audits and applicable assessments.
- Interpret, explain, and apply applicable current governmental regulations, guidelines, policies, and procedures to study protocols and related activities.
- Prioritize activities to ensure study/program objectives are met.
- Interact with Development Operations and supporting functions to ensure quality compliance across clinical development; identify and mitigate clinical quality risks and escalate to management; provide quality leadership across clinical development functions.
- Anticipate and determine present/future business needs in support of quality for a drug development program.
- Lead the articulation and presentation of an integrated cross-functional comprehensive quality strategy plan.
- Identify and implement fit-for-purpose quality management and develop/recommend strategies for success.
- Identify/remove barriers impacting objectives, priorities, timelines, and quality; communicate risks and mitigations to management.
- Serve as primary program quality liaison during health authority inspections.
Qualifications:
- Bachelor’s degree in a physical science, life science, nursing, pharmacy, or equivalent experience (required).
- 5+ years pharmaceutical industry experience in GCP quality assurance, regulatory affairs, clinical development, or clinical operations (oncology a plus; prefer 1+ years GCP QA auditing).
- Progressive leadership experience; strong problem-solving at strategic/operational levels.
- Demonstrated strategic planning and cross-functional execution; track record managing projects supporting clinical research.
- Strong understanding of global Pharma/clinical development/operations and regulatory environments.
- Experience preparing/presenting key information.
- Comprehensive knowledge of interrelationship among RDQA GXP functions and business functions.
Benefits (if applicable per posting):
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for long-term incentive programs.
Location:
North Chicago, IL; Irvine, CA; South San Francisco, CA; Worcester, MA; Dublin, Ireland; Maidenhead, UK.