Responsibilities will include, but are not limited to, the following:
1. Assess GLP compliance for global nonclinical development within each function conducting or supporting nonclinical laboratory studies.
2. Maintain lead responsibility for the Quality Assurance Unit (QAU) to assure that Nonclinical laboratory studies are monitored throughout their conduct and reporting for compliance with GLP regulations.
3. Maintain a copy of the master schedule of all nonclinical laboratory studies indexed by test article, test system, nature of study, date study was initiated, current status of each study and name of study director.
4. Maintain copies of protocols and protocol amendments for all nonclinical laboratory studies.
5. Assure the QAU performs the following:
6. Implement and monitor global QA oversight of contract laboratories conducting or supporting nonclinical laboratory studies sponsored by the company.
7. Assure contract laboratories conducting or supporting nonclinical development sponsored by Celgene are qualified from the GLP compliance perspective prior to use.
8. Ensure test and control article characterization and handling comply with GLP requirements.
9. Assess GLP awareness and GLP compliance training needs for all employees managing and/or conducting nonclinical laboratory studies or supporting nonclinical development.
10. Develop and provide GLP awareness and GLP compliance training across the company for those employees involved in conducting or supporting nonclinical development including formal effectiveness assessment and GLP training certification for each employee.
11. Partner, interact closely and establish strong liaison with global business partners in Research & Development, i.e. Early Drug Development, Analytical Development, Information Technology, Quality & Compliance, Non-clinical Supplies and Regulatory Affairs to ensure consistent global GLP compliance understanding.
12. Identify opportunities for process improvement; plan, implement and evaluate changes in conjunction with corporate and department goals.
13. Assist in the review and development of Nonclinical Development SOPs and Working Practices.
14. Assist in preparation of budget and strategic plan for GLP compliance (QAU).
15. Remain current in state of the art understanding of GLP compliance on a global basis including regional compliance enforcement experience with Health Authorities.
PRE-REQUISITES BS/BA degree in Biomedical or Health Care related sciences (Masters preferred) 5+ years of combined experience in conducting nonclinical laboratory studies and auditing nonclinical studies for compliance with Good Laboratory Practice (GLP) regulations in the pharmaceutical industry or contract laboratories.
Thorough knowledge of the nonclinical drug development process
Thorough understanding of FDA GLP regulations, OECD GLP Principles and local GLP requirements
State of the Art awareness of compliance enforcement strategy undertaken by regional health authorities
Excellent interpersonal, facilitation, presentation and communication skills with demonstrable tact and diplomacy
Demonstrated ability to function in a team environment
Experience developing, implementing and evaluating SOPs
Ability to function in a highly matrixed organization
Willingness to travel (up to 30%)