Senior Manager, Clinical Quality Assurance

AbbVie

Confirmed live yesterday High trust
Hybrid

Quick summary

Work type
Hybrid
Location
North Chicago, ILCambridge, MAWorcester, MAIrvine, CASan Francisco, CAFlorham, NJ
Salary
$124,500–$236,500 / yr
Posted
15 days ago
Freshness
Confirmed live yesterday
Closes
Aug 27, 2126

Market check

Salary context

Competitive pay

How this pay compares to similar roles

Similar $185k
This role $180k
$111k most similar roles pay here $250k

This role pays more than 51% of similar roles. Most pay $156,475–$212,600 — the shaded band above. At the midpoint, this role pays about $180k versus about $185k for comparable roles.

Based on 239 similar postings.

Employer

About AbbVie

AbbVie is a global biopharmaceutical company focused on discovering and delivering innovative medicines and solutions in immunology, oncology, neuroscience, and eye care. Its products include Humira, Skyrizi, and Rinvoq.

AbbVie currently has 297 open roles on FindRole.

Listed pay typically runs $109,500–$208,500 across 271 roles with salary data.

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View all roles at AbbVie

At a glance

TL;DR · Senior Manager, Clinical Quality Assurance

Senior Manager, Clinical Quality Assurance - Americas joins the RDQA organization to drive quality excellence across all stages of discovery and development for the product lifecycle. This role focuses on proactive quality management within the Americas region to ensure first pass approvals from health authorities. The manager is responsible for implementing quality systems including CAPA, change management, and risk management while overseeing compliance in a regulated environment. Key responsibilities include developing risk mitigation strategies, conducting audits, managing vendor qualifications, and providing inspection-readiness support for local health authority inspections. The ideal candidate possesses a degree in a medical science field and extensive experience in biopharmaceutical quality assurance and regulatory affairs. Core competencies include strong analytical skills, cross-functional collaboration, and the ability to influence others while navigating complex global regulations to ensure data integrity and clinical research excellence.

What you'll do

  • Implement and execute proactive quality management activities for clinical research across assigned countries and regions.
  • Oversee quality and compliance in regulated environments according to company policies and regional standards.
  • Develop risk identification, mitigation strategies, and control plans for clinical research activities.
  • Manage governance and oversight of the One AbbVie Quality System to ensure regulatory preparedness.
  • Conduct audits to assess compliance with regulations and approve corrective action plans.
  • Support supplier visits, vendor qualifications, and provide inspection-readiness support for health authority inspections.
  • Provide oversight and follow-up for local health authority inspections including report responses.
  • Mentor and coach team members on audit responses and quality management processes.

What we're looking for

  • Bachelor's degree required in Biology, Nursing, Pharmacy, or another medical science field.
  • 8+ years of biopharmaceutical or medical device industry experience in quality assurance, compliance, regulatory affairs, or clinical research.
  • 3 years of experience in leadership positions involving people, initiatives, or projects.
  • Thorough knowledge of quality systems, auditing standards, and quality management.
  • Strong understanding of local and global regulatory and legal requirements for clinical research.
  • Excellent written and oral communication skills including presentation and influencing abilities.
  • Ability to foster cross-functional collaboration and build relationships with stakeholders at all levels.
  • Ability to travel as needed in the assigned region up to 35% of the time.

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