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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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Clinical QA Manager-Americas

Primary Lake County, Illinois Secondary Irvine, California Req ID R00096428 Category Research and Development Division AbbVie

This is a hybrid position out of our North Chicago, IL or Irvine, CA locations but remote work may be approved for the right candidate.

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

Responsibilities:

·       Maintain a close, collaborative relationship with RDQA functions impacting clinical research

within designated Affiliates in the assigned countries and region.

·       Establish collaborative-working relationship with clinical development leaders and staff within

designated Affiliates to advance the AbbVie Quality System, drive quality excellence, and

achieve first pass approval for market authorization by health authorities.

·       Oversee quality and compliance in a regulated environment including AbbVie policies and

procedures and country and regional standards and regulations.

·         Lead and/or collaborate on development of risk identification and risk mitigation or control

 strategies for clinical research activities including clinical trials within designated countries with

 periodic reviews of quality and compliance data for the purposes of continuous improvement.

·         Establish quality measures with the desire to achieve RDQA quality goals. Drive quality strategy

 in designated countries and region in conjunction with other RDQA AREA personnel.

·         Manage governance/oversight that is “fit for purpose” and in relation to the One AbbVie

 Quality System. Identify trends, root causes, and potential risks to mitigate and/or prevent

 issues that impact clinical research. Drive vision of continuous state of regulatory

 preparedness.

·         Ensure consistent understanding of the quality requirements for clinical research activities

 within Affiliates, works closely with Affiliates R&D Management on health of Quality System,

 identifies issues of quality and compliance that will impact overall goals and desired outcomes.

·         Maintain awareness of all applicable regulations and develop appropriate standards to measure

 quality in assigned countries and region relating to clinical research.

·         Support necessary supplier visits, audits and vendor qualifications

·         Develop inspection strategy in collaboration with AREA Associate Director and relevant

 functions and provide inspection-readiness support for all local / regional Health Authority

 inspections.

·         Provide oversight, support and follow-up (inspection report response) for local Health Authority

 inspections with employees and management in assigned countries and region. Participate in

 Health Authority inspections as needed.

·         Determine need for country/process assessments/audits in collaboration with Clinical Audit and

 Clinical PM.

·         Conduct audits as required to assess compliance with regulations, guidelines, policies and

 procedures and Sponsor requirements. Effectively communicate audit results, both orally and

 in writing. Review and approve corrective action plans/audit responses.

·         Support the development of robust audit and inspection responses through coaching and

 education.

·         Mentor AREA Managers/AREA Associates or line management as additional Lead responsibility.


Qualifications:

·Bachelor's degree required preferably in Biology, Nursing, Pharmacy, or other medical science

      degree combined with equivalent technical experience. 8+ years of biopharmaceutical /

medical device industry experience in quality assurance, compliance, regulatory affairs,

clinical research and/or other related development functions that includes 3 years in

leadership positions (people and/or initiatives/projects).

·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%).


AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.


Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Travel: Yes, 25 % of the Time

Job Type: Experienced

Schedule: Full-time

Compensation

Minimum Salary $109,500

Maximum Salary $208,000

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