Director, Preclinical Quality Assurance

About the role

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

Responsibilities

• Management of the Preclinical Quality Assurance Team including the Preclinical QA Audit Program. Ensure adherence to GLP and GCP laboratory regulations. 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.
• Develop an organizational model for internal GLP audit coverage and ensure appropriate capabilities and resources exist.
• Consultation with Test Facility Management, Study Directors and Principal Investigators regarding GLP and laboratory GCP requirements. Advocate for Quality standards and clearly and logically justify such positions to be seen as a subject matter expert and advisor.
• Evaluation of new respectively revised regulatory or legal requirements as they apply to non-clinical laboratories including study activities. Where applicable, initiation of implementation in the R&D Quality System.
• Attend Peer Industry working groups on relevant topics in GLP, GCP and other laboratory relevant regulatory guidance. Conduct of industrial benchmarking.
• Define quality goals for both annual and long-range plans. Work with management and department personnel to achieve goals and strategic initiatives.
• Support the Pre-Clinical Due Diligence activities 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.
• Coverage of functional area management review; preparation of appropriate metrics and presentation of significant events to senior management.
• Definition and execution of goals and personnel development plans within the group. Provision of annual performance reviews for direct reports. Recommendation of hiring, promotion and disciplinary action for staff.

Requirements

• 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.

Qualifications

• Bachelor's degree or equivalent experience is required; preferably in sciences, engineering or other technical/scientific area.

Skills

• 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.

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Pay

$182,000 - $346,000 USD

Schedule

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.