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.
- 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.
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.
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.
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