Director, GLP Quality Assurance

Purpose:

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.

Responsibilities:

 

• 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.

12+ years of experience in Quality Assurance with demonstrated experience of leading a QAU audit program and strategy, including a thorough understanding of pharmaceutical processes and product development principles, technical competence in bioanalytical laboratory operations and expert knowledge of global GLP regulations.

Direct experience with line managing a team of audit professionals.

Key leadership competencies include engagement, visibility, relationship building, conflict resolution, cultural awareness, sound judgement and the ability to influence at all levels.

Must have demonstrated 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. 

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.

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.