Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

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 peoples
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
products 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 AbbVies 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 AbbVies 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 AbbVies 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.

Qualifications

Bachelor's degree preferably in Biology, Nursing, Pharmacy, or other science-based degree.

Additional Information

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, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein our long-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 employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat 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