Quality Assurance and Regulatory Managers

IT Regulatory Quality Assurance Manager (Hybrid) 3.8 3.8 out of 5 stars Company Description 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 at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The IT Regulatory Quality Manager, is a key member of the Software Quality Assurance (SQA) team, responsible for ensuring that AbbVie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role requires strategic leadership in defining, implementing, and optimizing quality 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 and maintaining effective service agreements. Key Responsibilities: Develop, implement, and champion solution/change strategies that align with organizational objectives and 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, facilitating knowledge-sharing sessions, and supporting onboarding on Quality Assurance policies and practices. Oversee proper documentation and evidence management processes to maintain compliance 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, and maintaining the 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 and timely risk assessment submissions to preserve compliance and business continuity. Develop, monitor, and interpret SQA metrics and trends, utilizing data-driven approaches to identify quality 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/applications disposition, migration, or decommissioning, and guidance for compliant integration. Collaborate across functions to monitor M&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 about identified risks, quality findings, and recommended actions.

Qualifications

Bachelor's degree with minimum 7 years' relevant experience, or Master's degree 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, and strong communication proficiency, with the ability to influence and work effectively across diverse teams. Proficiency in 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. 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 short-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. 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, visit https://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 Apply tot his job Apply To this Job