Senior Audit Manager, GLP/GCPLocation Apply
BioMarin is a global, high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, self-motivation and organization are essential role requirements. This position will play a key role in executing BioMarin’s GxP Compliance Program. The overall purpose of this program is to ensure continuous compliance with applicable global GxP regulations and BioMarin quality requirements through periodic assessments of internal operations; domestic and international third parties (i.e. testing facilities, contract research organizations, analytical laboratories) responsible for conducting non-clinical laboratory studies intended to support research and marketing of products regulated by government agencies. The primary responsibility of the position is the planning and execution of GCP /GLP audits to assess ongoing compliance with government regulations and corporate standards of BioMarin internal sites and external third parties. All employees are required to follow defined processes and policies; behave in a professional manner with integrity and strive for right first time performance.
- Assist in the monitoring and evaluation of compliance for nonclinical, clinical and bioanalytical studies conducted by BioMarin in accordance with FDA Good Laboratory Practices (GLP) and Good Clinical Practice (GCP) regulations, OECDs principals and any other applicable GCP /GLP international regulations, corporate policies and standard operating procedures (SOPs)
- Support GxP Compliance Management in assessing the company's compliance with government regulations, guidelines, scientific protocols and internal SOPs with respect to nonclinical, clinical and bioanalytical studies conducted by Biomarin
- Prepare and lead GCP /GLP audits across multiple internal sites and third parties both domestic and international
- Review study protocols, raw data, data summary tables, technical reports, final reports associated with nonclinical and bioanalytical studies (method validations and study sample analysis) conducted by BioMarin to evaluate regulatory compliance
- Conduct GCP audits of vendors such as CROs, clinical and bioanalytical laboratories, central imaging /central reading, home healthcare agencies, translation companies, central IRBs and biospecimen storage facilities
- Identify compliance risks related to areas of GCP /GLP and develop sound rational for observations against current regulatory requirements and standards
- Provide timely audit reports, timely data entry into the data tracking systems and evaluate corrective action plans
- Assist in the development and training of audit team members
- Develop and improve compliance processes, integrate global systems and provide related training to stake holders as necessary
- Serve as an internal consultant in interpretation of GCP /GLP regulatory requirements and expectations
- Represent Compliance in various forums and project teams
- Domestic and International travel required (>30%)
- Other duties as assigned.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.