Senior Audit Manager, GLP Compliance (Non-Clinical Laboratory Studies)

Location
Working from Home
Posted
Jun 29, 2021
Ref
obgAffw0
Required Education
Bachelors Degree
Position Type
Consultant

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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. non-clinical testing facilities) 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 GLP audits related to non-clinical laboratory studies 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.

Key Responsibilities

Assist in the monitoring and evaluation of compliance for nonclinical studies conducted by BioMarin in accordance with US FDA regulations (21 CFR Part 58) and any other applicable GLP international regulations, corporate policies and standard operating procedures (SOPs)

Prepare and lead GLP audits related to non-clinical laboratory studies across multiple internal sites and third parties both domestic and international

Support GxP Compliance Management in assessing the company's compliance with government regulations, guidelines, scientific protocols and internal SOPs with respect to non-clinical laboratory studies conducted by Biomarin

Review study protocols, raw data, data summary tables, technical reports, final reports associated with non-clinical and bioanalytical studies (method validations and study sample analysis) conducted by BioMarin to evaluate regulatory compliance

Identify compliance risks related to areas of GLP for non-clinical laboratory work 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 the interpretation of GLP regulations associated with non-clinical laboratory studies

Represent Compliance in various forums and project teams

Domestic and International travel required (>30%)



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.