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This position has closed. AbbVie removed this listing from their careers page on Oct 6, 2026. The interview prep below is still useful, and there are similar open roles at the bottom of this page.

Senior Manager, Safety, Medical & Regulatory Quality

AbbVie · North Chicago, IL · Remote available · Full time · Quality Assurance

Posted Sep 1, 2026 · We last checked this listing on Oct 5, 2026

Likely interview questions for this role

Written from this job description, not a generic list. Each one notes what the interviewer is really checking.

About your past

This role provides independent quality oversight of safety, regulatory affairs or medical affairs activities within research and development quality assurance. What quality assurance work have you done in one of those areas?

What they are checking: Whether they have done quality assurance in safety, regulatory or medical affairs specifically, since general quality work does not cover these areas.

What would you do

What does independent oversight actually mean in practice when the people you oversee are colleagues?

What they are checking: Whether they understand that independence means judging objectively even with colleagues, because a quality function is only useful when impartial.

You find a compliance gap and the business function disputes it. How do you handle that?

What they are checking: Whether they can stand by a sound finding while listening fairly, since quality oversight fails if findings are dropped under pushback.

The posting names successful business partner collaboration. How do you stay a partner while also being the one who inspects them?

What they are checking: Whether they can keep good working relationships with the teams they audit while still reporting problems honestly and firmly.

An inspection is announced with short notice. What do you do first?

What they are checking: Whether they know the first steps for a short-notice inspection, like organizing documents and briefing staff, and stay calm doing them.

This contributes to managing a global team at North Chicago. What would you want to know about the team and the audit plan before you took it?

What they are checking: Whether they ask about the team and audit plan before accepting, which shows they think about what they would inherit.

About the work

The role covers clinical trials, post-market vigilance and post-market studies. Which of those do you know best, and which would be new?

What they are checking: Whether they can honestly say where they are strong and where they would need to learn across a wide regulatory scope.

How do you audit a pharmacovigilance process so the finding holds up with an inspector?

What they are checking: Whether their audits are rigorous enough to hold up with an inspector, with clear evidence and documentation behind each finding.

The posting names data integrity. Where does data integrity actually break down in safety reporting?

What they are checking: Whether they can name where safety data actually breaks down, like case processing and reconciliation, rather than defining the term.

The portfolio covers drugs, devices and cosmetics. What changes about quality oversight across those three?

What they are checking: Whether they understand that drugs, devices and cosmetics fall under different rules, and adjust oversight to fit each one.

Practice this interview out loud.

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The full job description

As published by AbbVie.

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution of clinical trials, post market vigilance and post market studies, assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs. Senior Manager, Safety, Medical & Regulatory Quality contributes to the management of a RDQA global Safety, Regulatory Affairs (RA) or Medical Affairs (MA) QA team which provides independent quality oversight of safety activities executed by AbbVie’s R&D and non-R&D business functions, covering the AbbVie drug, device and cosmetic portfolio. The role contributes to quality excellence through successful business partner collaboration and provides expert technical quality support and consultation to R&D colleagues and business partners. May support Regulatory Agency inspections. The role reports to the Director Safety, Medical & Regulatory Quality. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large. Responsibilities: • Contribute to a state of continuous compliance with global regulations, AbbVie policies and procedures and regulatory preparedness for relevant Regulatory Authority Inspections and pharmacovigilance and safety inspections and deliver business results while positioning AbbVie for future success • Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset and people leadership manage innovation to reality. • Fulfil expectations and goals to ensure organizational success. Embody a culture of open and honest communication where all are encouraged to express their views, offer suggestions and experiment for improvement. • Support and execute a holistic quality assurance model for applicable GxP activities, inclusive of internal and vendor performed activities and ensure integration with interfacing GxPs and cross functional alignment. Support the delivery of innovative quality strategies and solutions through influence and collaboration with business partners to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings impacting safety, RA and MA. • Determine and evaluate risks impacting compliance with GxP requirements and proposing suitable mitigations. • Support business process owners directly to ensure quality is integrated at all stages of process development. • Actively participate in front and/or back-room Regulatory Authority inspection activities to enable successful inspections with safety, RA and MA topics in scope. • Is recognized as a partner for consultation regarding worldwide safety, regulations and corporate policies, especially for CAPA and associated Quality disciplines. • Generate, analyze and report metrics to demonstrate key aspects of compliance status, escalating issues in a timely manner for earliest resolution and ensuring the value of QA is recognized and acknowledged • Contribute to the development and implementation of systems and processes required to support implementation of global QA strategies. Contribute with applicable RDQA business functions to provide support, input and consultation to ensure an inclusive and effective RDQA audit program. • Drive necessary change and efficiency through the provision of effective feedback and recommendations; persists in pursuing and achieving organizational goals and objectives. • Create an impact by modeling the AbbVie Behaviors in a consistent and visible manner in the conduct of all responsibilities. • Bachelor's degree preferably in Biology, Nursing, Pharmacy, or other science-based degree. • 5 years of experience in the pharmaceutical industry in the fields of pharmacovigilance, regulatory affairs and/or quality assurance supporting those areas. • 5 years of experience in Quality Assurance. • Strong analytical skills and the ability to organize work in a logical, thorough, and succinct manner. Ability to work and interact with RDQA business partners and external partners. • Extensive knowledge of quality standards, worldwide regulatory requirements and industry best practices relating to safety, RA or MA. • Flexibility to adapt to changing assignments and ability to effectively prioritize with minimal supervision. Ability to work in a fast-paced, high pressure and changing environment in an autonomous manner. • Project management, interpersonal, and communication skills with ability to influence. • Comfortable working independently or as part of a team. • Strong communication and interpersonal skills. 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.​ 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