Senior Manager, RDQA (Americas)
AbbVie
August 19, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Operations
Purpose:
As part of AbbVie’s independent RDQA organization, drive proactive quality excellence across discovery and development to support product realization and accelerate access to innovative therapies.
Major Responsibilities:
- Support assigned countries/region; implement proactive quality management for clinical research/R&D activities.
- Collaborate with RDQA functions and affiliate clinical development leaders to advance the AbbVie Quality System and achieve first-pass approvals for market authorization.
- Oversee quality/compliance in regulated environments; ensure alignment with policies, procedures, and local/regional standards.
- Lead and/or collaborate on risk identification and mitigation strategies; perform periodic reviews of quality/compliance data for continuous improvement.
- Establish quality measures and drive RDQA quality goals; monitor trends, root causes, and potential risks.
- Maintain awareness of applicable regulations; develop standards to measure quality.
- Support supplier visits, audits, vendor qualifications; develop inspection strategy and provide inspection-readiness support.
- Provide oversight and follow-up for health authority inspections, including corrective action plan/audit response review and approval.
- Conduct audits as required; coach and educate to strengthen audit/inspection responses.
- Mentor AREA Managers/Associates or provide additional lead responsibilities.
Qualifications:
- Bachelor’s degree (Biology, Nursing, Pharmacy, or medical science) plus equivalent technical experience.
- 8+ years in biopharmaceutical/medical device quality, compliance, regulatory affairs, and/or clinical research; includes 3 years in leadership positions.
- Strong knowledge of local/global regulations, quality systems, and auditing standards; ability to influence without authority.
- Excellent communication, analytical, negotiation, collaboration, and cross-functional leadership skills.
- Travel up to 35% as needed.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k).
- Eligible for long-term incentive programs.
As part of AbbVie’s independent RDQA organization, drive proactive quality excellence across discovery and development to support product realization and accelerate access to innovative therapies.
Major Responsibilities:
- Support assigned countries/region; implement proactive quality management for clinical research/R&D activities.
- Collaborate with RDQA functions and affiliate clinical development leaders to advance the AbbVie Quality System and achieve first-pass approvals for market authorization.
- Oversee quality/compliance in regulated environments; ensure alignment with policies, procedures, and local/regional standards.
- Lead and/or collaborate on risk identification and mitigation strategies; perform periodic reviews of quality/compliance data for continuous improvement.
- Establish quality measures and drive RDQA quality goals; monitor trends, root causes, and potential risks.
- Maintain awareness of applicable regulations; develop standards to measure quality.
- Support supplier visits, audits, vendor qualifications; develop inspection strategy and provide inspection-readiness support.
- Provide oversight and follow-up for health authority inspections, including corrective action plan/audit response review and approval.
- Conduct audits as required; coach and educate to strengthen audit/inspection responses.
- Mentor AREA Managers/Associates or provide additional lead responsibilities.
Qualifications:
- Bachelor’s degree (Biology, Nursing, Pharmacy, or medical science) plus equivalent technical experience.
- 8+ years in biopharmaceutical/medical device quality, compliance, regulatory affairs, and/or clinical research; includes 3 years in leadership positions.
- Strong knowledge of local/global regulations, quality systems, and auditing standards; ability to influence without authority.
- Excellent communication, analytical, negotiation, collaboration, and cross-functional leadership skills.
- Travel up to 35% as needed.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k).
- Eligible for long-term incentive programs.