Sr. Manager, IT QA- Regulatory Assurance

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.
• 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.
• 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

Benefits

Additional Information

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.

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