AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

The IT Regulatory Quality Manager,is a key member of the Software Quality Assurance (SQA) team, responsible for ensuring that AbbVies IT operations and software lifecycle processes fullycomply withregulatory requirements and corporate standards. This role requires strategic leadership in defining, implementing, andoptimizingquality systems, and involves direct collaboration with cross-functional teams, Business stakeholders, and the Business Technology Services (BTS) Quality organization.

The IT Regulatory Quality Manager will provide oversight of quality activities, especially across Mergers & Acquisitions (M&A), drive improvement initiatives, troubleshoot IT quality issues, and support all phases of the IT solution lifecycle. The incumbent acts as the primary point of contact between business units and quality teams, ensuring mutual understanding of needs andmaintainingeffective service agreements.

Key Responsibilities:

• Develop, implement, and champion solution/change strategies that align with organizationalobjectivesand evolving regulatory requirements.

• Lead continuous improvement initiatives, including enhancing quality assurance frameworks and promoting adoption of automation and advanced validation tools (e.g., pipelines, artificial intelligence).

• Monitor and proactively respond to changes in regulatory standards and industry best practices by updating SLC procedures and compliance processes.

• Serve as the primary SQA representative in strategic forums, steering committees, and regulatory engagements. Clearly communicate quality outcomes, audit results, and recommended improvements to partners and stakeholders.

• Support and manage regulatory audits and inspections, including preparing formal responses and overseeing remediation activities (CAPA implementation).

• Provide expert guidance and mentorship to cross-functional colleagues about computerized system quality practices, process optimization, and policy interpretation.

• Foster a culture of professional development by leading training initiatives,facilitatingknowledge-sharing sessions, and supporting onboarding on Quality Assurance policies and practices.

• Oversee proper documentation and evidence management processes tomaintaincompliance and facilitate SQA investigations, CAPA activities, and audit readiness.

• Act as deputy for the Center of Excellence (CoE) leadership as needed by managing SLC communications, curating newsletters, coordinating meetings, andmaintainingthe SLC SharePoint site.

• Serve as a key escalation point for significant quality exceptions, risks, and issues, coordinating investigations and resolutions with minimal supervision.

• Participate in infrastructure change management and risk review activities across multiple sites, including governance meetings andtimelyrisk assessment submissions to preserve compliance and business continuity.

• Develop,monitor, and interpret SQA metrics and trends,utilizingdata-driven approaches toidentifyquality gaps and prioritize improvements; prepare executive-ready dashboards and reports for senior leadership.

• Lead and perform due diligence for quality and compliance during mergers and acquisitions, ensuring all regulatory requirements and best practices are upheld.

• Provide expert oversight for M&A activities, including assessment of acquisition documentation, management of systems/applicationsdisposition, migration, or decommissioning, and guidance for compliant integration.

• Collaborate across functions tomonitorM&A integration, address compliance issues, and act as liaison with leadership teams, support functions, and regulatory authorities.

• Create and deliver training and comprehensive reports to educate teams and inform executive stakeholders aboutidentifiedrisks, quality findings, and recommended actions.

• Bachelors degree with minimum 7 years relevant experience, orMastersdegree with minimum 6 years experience, including at least 2 years of supervisory responsibility.

• Proven experience managing relationships with Managed Service Providers (MSP) and directing outsourced validation or SLC activities and

• Experience leading DevOps and Agile projects and hands on experience with DevOps toolset.

• Demonstrated analytical skills, sound judgment, consultative capability, andstrong communicationproficiency, with the ability to influence and work effectively across diverse teams.

• Proficiencyin automated pipeline technologies and advanced validation techniques.

• Deep understanding of software quality assurance and regulatory compliance requirements, including relevant industry standards and best practices.

• Experience in risk management, complex project oversight, and juggling multiple priorities in a dynamic environment.

• Direct experience supporting FDA and other regulatory agency inspections and interactions.

• Established project management experience, including training development and creation of knowledge materials.

• Ability to coach teams in policy, SLC execution, and regulatory requirements.

• Advanced knowledge of Computer Software Assurance (CSA) methodologies, data integrity, and contemporary validation practices.

• Professional certifications such as ASQ Certified Quality Auditor, Project Management Professional (PMP), Six Sigma, or equivalent.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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