Director, GLP Quality Assurance
- Lake County, Illinois
- Start date
- Mar 28, 2023
- Quality, Quality Assurance, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- BioMidwest, Best Places to Work
This position is responsible for ensuring adherence to Good Laboratory Practice (GLP) regulations and for developing an organizational model for the Quality Assurance Unit (QAU). Manage a team of audit professionals responsible for quality oversight of all GLP-regulated and bioanalytical studies.
- Lead the QAU auditing program for compliance of GLP-regulated in-house studies and regulatory dossiers prior to filing.
- Ensure adherence to GLP and GCLP regulations related to bioanalytical laboratories testing pre-clinical and clinical samples to maintain high standards of quality and compliance.
- Monitor current trends of regulatory agencies as they apply to pre-clinical studies and bioanalytical laboratories to ensure inspection readiness. Communicate the changing regulatory requirements, understand the impact of changes on other quality systems, and and drive change.
- Collaborate with Vendor Compliance to ensure GLP and GCLP external vendors, who provide materials and services on behalf of AbbVie, are appropriately approved prior to use.
- Define quality goals for both annual and long range plans. Work with management and the department personnel to achieve goals and strategic initiatives.
- Conduct functional area management review; prepare appropriate metrics and present significant events to senior management.
- Lead experienced audit professionals and help define and execute goals and personnel development plans within the group. Provide annual performance reviews for direct reports. Recommend hiring, promotion and development actions for staff.
Qualifications:Bachelor's degree or equivalent experience is required; preferably in sciences, engineering or other technical/scientific area.
AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.
Stock Symbol: ABBV
Stock Exchange: NYSE
1 North Waukegan Road
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