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.

Leads the strategic integration of Software Quality Assurance (SQA), Compliance, and BTS Technology Enablement teams deliveringthe Technology Solution Lifecycle (TSL)automation tools. Responsible for ensuringpharmaceuticalregulatory requirements (GxP, CSV, Part 11, Annex 11) are accurately interpreted, translated, and embedded into technology practices and CI/CD pipelines. Accountable foridentifyingstrategic business opportunities, shaping compliant technology solutions, leading process modernization, and ensuring alignment of digital quality engineering with business and regulatory expectations across multiple business areas.

Responsibilities

• Lead as the primary liaison between SQA and Compliance leaders and BTS technology enablement teams; broker services, align stakeholders, and resolve interdependencies across multiple business areas.
• Responsible for analyzing business strategies, processes, and regulatory drivers across business units toidentifyneeds and opportunities for quality and compliance improvement enabled by technology.
• Accountable for interpreting and translating compliance and quality requirements (GxP, CSV, Part 11, Annex 11, SLC) into epics, user stories, acceptance criteria, functional specifications, and process changes.
• Lead development, maintenance, and validation of traceability matrices linking requirements, controls, system design, and verification evidence; ensure inspection-ready documentation.
• Partner with development, DevOps, and automation teams to embed compliant quality controls into TSL tools, including risk profiling, requirements/design management, CI/CD, testing, deployment, and monitoring.
• Lead significant cross-functional improvement programs, including shift-left testing, risk-based validation, automation,andprocess simplification.
• Responsible for ensuring compliance with Corporate and Divisional policies, standards, and governance; evaluate solution alternatives using standard IS methodologies andassessregulatory impacts.
• Lead integration efforts with BTOs/BTS teams,maintainstrong cross-functional relationships, broker services, manage interdependencies, and support customer engagement.
• Lead a significant area of work with technical, financial, and quality accountability;establishobjectives, delegate assignments, develop talent, and deliver training and awareness on compliant quality engineering and regulatory changes.

Required:

• Bachelor's Degree with 8 years experience; Master's Degree with 7 years experience; PhD with 3 years experience.
• Exercises latitude in the approach to problem solving.
• Work checked through consultation and agreement with others rather than formal review by superiors.
• Familiarity with key regulatory domains (GxP, SOX, PCI, Privacy, Toxins, Security, Cybersecurity, NIS2, AI, Accessibility, etc).
• Experience with controls frameworks

Preferred:

• Experience working across multiple business areas within BTS/BTO.
• Experience supporting audits/inspections and leading CAPA remediation.
• Experience driving automation, compliance modernization, or validation transformation programs.

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 postingbased on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypaymore 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 untilpaid 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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html