AbbVie

Sr. Manager, IT QA- Regulatory Assurance

AbbVie$120K — $150K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree with 8 years experience; or Master's with 7 years; or PhD with 3 years.
  • Experience in Software Quality Assurance (SQA), Computer System Validation (CSV), and auditing.
  • Minimum 2 years in a leadership role overseeing quality professionals.
  • Expertise in regulatory compliance, process improvement, and audit management.
  • Proven track record in developing enterprise-level validation strategies and policy frameworks.
  • Strong understanding of modern technologies including cloud, AI/ML, and automated testing.
  • Experience in managing cross-functional teams and vendor relationships.

Responsibilities

  • Provide strategic leadership in IT Quality Assurance activities ensuring regulatory compliance.
  • Lead and mentor a high-performing IT Quality team; support their development and growth.
  • Design and implement automation solutions to enhance Software Lifecycle (SLC) efficiency.
  • Oversee validation strategy and harmonization of quality processes across the enterprise.
  • Manage enterprise-level audits and inspections; lead audit defense efforts.
  • Optimize vendor documentation and partner management for quality and compliance oversight.
  • Utilize metrics and dashboards to drive data-driven decision-making in IT operations.

Benefits

  • Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).
  • Opportunity to participate in long-term incentive programs.
Full Job Description
Job Description

The Senior Manager, IT Quality is responsible for elevating AbbVie's IT operations and software quality practices by ensuring full compliance with regulatory requirements and corporate standards, while providing advanced strategic leadership across process improvement, risk management, and validation strategies. This role leads to the development and implementation of quality systems and processes by leveraging digital enablement, data-driven methodologies, and emerging technologies including automation, AI, and advanced analytics. Collaborating directly with cross functional teams, the Senior Manager provides audit and inspection support, Corrective Action and Preventive Action execution in the Business Technology Solutions Quality area, and adoption of vendor documentation, strengthening operations through proactive risk mitigation and fostering operational excellence.

Additionally, the Senior Manager leads and develops a high-performing IT Quality team, manages critical partnerships and contracts, and champions continuous process improvement, technology adoption, and innovation. With a keen eye for automation opportunities and a strong commitment to stakeholder efficiency, this role acts as the primary liaison for quality assurance initiatives, policy frameworks, audit readiness driving high-impact results and aligning business and regulatory objectives across AbbVie's technology landscape.

Responsibilities:
  • Provide advanced strategic leadership in the analysis, oversight, and execution of IT Quality Assurance activities, ensuring compliance with regulatory requirements and corporate procedures across all IT operations and projects.
  • Lead, mentor, and develop a high-performing IT Quality team, including direct supervision of managers and principal engineers; set clear expectations, provide coaching, and ensure professional growth.
  • Lead the design and implementation of advanced automation solutions and digital tools, applying expert solution-building skills to streamline Software Lifecycle (SLC) activities, reduce manual effort, and accelerate delivery of compliant IT solutions across the enterprise.
  • Architect and oversee validation strategy, policy framework development, and harmonization of quality processes enterprise-wide, ensuring alignment with business and regulatory objectives.
  • Drive enterprise-level audit and inspection support, including leading audit defense, crafting responses to inspection findings, and managing the deployment and closure of CAPA solutions across functional areas.
  • Oversee and optimize the use of vendor documentation, partner management, and contract oversight to ensure partner performance, quality deliverables, and compliance with SLAs.
  • Utilize advanced metrics, KPIs, and dashboards to monitor IT system health, assess operational risks, and drive data-driven decisions for continuous improvement.
  • Proactively identify and enable opportunities for process automation and technology adoption that increase efficiency, stakeholder satisfaction, and audit-readiness.
  • Engage, influence, and align cross-functional partners, executive stakeholders, and BTS Quality leadership to advance strategic technology investments and quality initiatives.
  • Foster a culture of innovation, standardize best practices and templates, promote lessons learned, and champion continuous improvement throughout the IT Quality function.


Qualifications

Required:
  • Bachelor's Degree with 8 years' experience; Master's Degree with 7 years' experience; PhD with 3 years' experience.
  • Experience in SQA, CSV, investigations, and/or auditing.
  • At least 2 years in a formal people management and supervisory capacity leading quality professionals and managers.
  • Demonstrated expertise in regulatory assurance, process improvement, enterprise risk management, automation, validation strategy, and leading audit/inspection responses.
  • Proven ability to develop and execute policy frameworks, validation strategies, and process harmonization initiatives at the enterprise level.
  • Strong technology acumen, with advanced knowledge of cloud, automated testing, AI/ML applications, advanced quality analytics, and modern Computer Software Assurance (CSA) practices.
  • Experience managing cross-functional teams, overseeing vendor/partner relationships, contract management, resource allocation, and budgeting.
  • Superior communication and influencing skills, with established success engaging executive sponsors, external partners, regulators, and internal stakeholders.
  • Track record of leading team development, coaching, and driving high performance across diverse IT Quality functions.

Preferred:
  • Preferred certifications: ASQ Certified Quality Auditor, PMP, Six Sigma, or equivalent.


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at AbbVie.

Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ

Similar Jobs

More Jobs at AbbVie

More Pharmaceuticals & Biotech Jobs

  • Director, Customer Success
    $150K — $250K *
    NAYA Therapeutics
    Chicago Heights, IL 60411 (Cook County)
  • Director, Customer Success
    $150K — $250K *
    NAYA Therapeutics, Inc.
    Deming, NM 88030 (Luna County)
  • CSV Engineer
    $100K — $130K *
    Katalyst HealthCares and Life Sciences
    Seattle, WA 98115 (King County)
  • Lab Technician
    $70K — $115K *
    Blueland
    Boca Raton, FL 33433 (Palm Beach County)
  • Thermo Fisher Scientific
    Staff QA Engineer
    $90K — $120K *
    Thermo Fisher Scientific
    Greenville, NC 27858 (Pitt County)

Find similar Sr. Manager, IT QA- Regulatory Assurance jobs: