AbbVie

Director, Quality Assurance

AbbVie • $140K — $180K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
4 days ago
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Job Overview by Ladders

Qualifications

  • 10+ years in Quality Assurance or related field with deep knowledge of GLP regulations.
  • Demonstrated leadership competencies in building relationships and influencing at all levels.
  • Strong decision-making skills and ability to respond rapidly to development program needs.
  • Expertise in project management and resolving complex technical problems.
  • Professional accreditation (e.g., ASQ Certified Quality Manager) is desirable.
  • Active membership in relevant professional organizations recommended for industry engagement.
  • Bachelor's degree in a relevant field is required; advanced science or engineering preferred.

Responsibilities

  • Manage compliance audits for GLP-regulated studies and regulatory dossiers.
  • Ensure adherence to GLP and GCLP regulations across bioanalytical lab testing.
  • Develop and maintain an organizational model for GLP/GCLP audit functions.
  • Monitor regulatory trends and communicate changes impacting quality systems.
  • Advocate for Quality standards, acting as a subject matter expert.
  • Define quality goals and collaborate with management to meet strategic initiatives.
  • Lead Due Diligence program for RDQA and assess targeted assets for business development.

Benefits

  • Comprehensive benefits package including paid time off and insurance.
  • 401(k) plan for eligible employees.
  • Participation in long-term incentive programs.
Full Job Description
Job Description

Purpose:

Primarily responsible for ensuring adherence to GLP regulations and developing an organizational model for the Quality Assurance Unit. Manage a team of audit professionals responsible for quality oversight of all GLP-regulated studies.

Poor decisions could present significant risks to patients in clinical trial programs, jeopardize the outcome of pre-clinical or clinical trials with resulting adverse business impact, or result in rejection of regulatory filings owing to compliance issues. These outcomes would adversely affect sales, margin, and stockholder value.

Responsibilities:
  • Manage auditing for compliance of all GLP-regulated in-house studies and regulatory dossiers prior to filing. Collaborate with GXP Vendor Compliance to ensure all external vendors, who provide materials and services on behalf of AbbVie, are appropriately approved prior to use.
  • Ensure adherence to GLP and GCLP regulations related to bioanalytical laboratories testing pre-clinical and clinical samples
  • Develop an organizational model for internal GLP and GCLP audit coverage and ensure appropriate capabilities and resources exist.
  • Monitor current trends of regulatory agencies as they apply to pre-clinical studies and bioanalytical laboratories. Communicate the changing regulatory requirements, understand the impact of changes on other quality systems and manage and drive change.
  • Advocate for Quality standards and clearly and logically justify such positions to be seen as a subject matter expert and advisor.
  • Define quality goals for both annual and long range plans. Work with management and the department personnel to achieve goals and strategic initiatives.
  • Lead the Due Diligence program for RDQA. Work with Business Development to ensure appropriate cross-functional assessment of targeted asset(s) and consolidate all RDQA Due Diligence findings for communication/recommendation to Business Development.
  • Conduct functional area management review; prepare appropriate metrics and present significant events to senior management.
  • Define and execute goals and personnel development plans within the group. Provide annual performance reviews for direct reports. Recommend hiring, promotion and disciplinary action for staff.


Qualifications

  • 10+ years of experience in Quality Assurance or related field including a thorough understanding of pharmaceutical processes and product development principles, technical competence in bioanalytical laboratory operations and expert knowledge of global GLP regulations.
  • Key leadership competencies are relationship building, ability to influence at all levels, fostering teamwork, knowledge of the business, sound judgment, the ability to make difficult decisions, conflict resolution, strong oral and written communication skills and excellent interpersonal skills.
  • Ability to make critical, creative and strategic decisions as a result of rapid analysis of available information, including risk-assessment for the patient and for the business. Must be able to respond quickly to unplanned events and changing needs from development programs.
  • Skilled in the selection, coordination and management of projects and have ability to resolve unusually complex technical problems by providing solutions that are highly innovative.
  • Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA)).
  • Membership in professional organizations, e.g. Midwest Discussion Group, SQA and IQ Consortium, recommended for remaining current with peer organizations and providing opportunity to influence industry positions.
  • Bachelor's degree or equivalent experience is required; preferably in sciences, engineering or other technical/scientific area.


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 thisposting 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 anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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