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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
This hybrid role could be based at any of AbbVie's location in the US such as North Chicago, IL Cambridge, MA, Worcester, MA Irvine, CA, San Francisco, CA or Florham, NJ
Purpose: As an independent RDQA Organization, our commitment is to drive quality excellence as a strategic advantage across all stages of discovery and development for the lifecycle of the product to achieve
product realization and to accelerate access to innovative therapies for our patients. AbbVie’s R&D
global trial footprint has been expanding due to growth in the pipeline and the complexity of global
development resulting in an overall increase in global trials in the Affiliates. In addition, the
acquisition of Allergan and integration with AbbVie have significantly increased clinical trials managed
from the Affiliates. RDQA AREA focuses on proactive quality and quality output in support of clinical
development/R&D enterprise within designated countries around the world.
AREA supports countries in Europe, Americas and Intercontinental as defined by AbbVie. The
expected results in the Affiliates are as follows; quality excellence, realization of R&D goals and
objectives for submission of new therapies including but not limited to adherence to One AbbVie
Quality System, execution of RDQA Quality System Excellence (CAPA, Change Management, Quality
Risk Management, Documentation Standards) and the assurance of integrity data. Scope includes
R&D and clinical research activities conducted by Affiliates or AbbVie within the region, to achieve
first pass approvals thereby advancing the pipeline.
This position will report to RDQA Associate Director or RDQA Global Director, AREA
Strong understanding of local and global regulatory and legal requirements and of the
approach and perspectives of regulatory agencies. Ability to ensure strategic risk focus with
evolving global regulations and expectations. Agile and able to respond rapidly to unplanned
events and changing regulatory requirements and expectations.
Thorough knowledge of quality systems, auditing standards and quality management.
Motivates and can influence others, including those over whom they have no direct authority.
Strong analytical skills with an ability to organize work in a logical, thorough & succinct
manner.
Ability to work at an experienced level, demonstrating effective leadership in interactions
with business partners at all levels.
Excellent written & oral communication skills including presentation and influencing skills.
Strong negotiation, influencing and collaborating abilities with excellent networking skills.
Ability to foster cross functional collaboration teams.
Strong team player or team lead and builds relationships with peers and cross-functionally at
both global and local levels to drive performance.
Fluent in additional languages desirable but not required.
Ability to travel as needed in AREA (up to 35%).
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 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: