Senior Manager, RDQA; Americas

Purpose:

As part of Abb Vie's independent RDQA organization, drive proactive quality excellence across discovery and development to support product realization and accelerate access to innovative therapies.

• 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 Abb Vie 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.

• 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.

• Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k).
• Eligible for long-term incentive programs.