Assessment Manager, GLP Compliance
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.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
Independent evaluation of compliance of nonclinical and bioanalytical studies conducted by BioMarin to FDA Good Laboratory Practices (GLP) regulations and any other applicable GLP international regulations and guidelines, and to corporate policies and standard operating procedures (SOPs). Plan and perform domestic and international GLP audits to assess the company's compliance to FDA government regulations, scientific protocols and internal SOPs as they relate to GLP Quality Assurance and regulatory GLP compliance. In addition, perform systems audits and due diligence reviews. Interpret and communicate findings to the appropriate management. Coordinate GLP regulatory compliance training events and participate in special GLP Compliance system and corporate projects.
· Works on extremely complex problems and significant issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Creates formal networks with key contacts outside own area of expertise, involving coordination among groups.
· Act independently to determine methods and procedures on new or special assignments. May coordinate and/or supervise the activities of other personnel (Team Lead).
· Review study protocols, raw data, data summary tables, technical reports, final reports and submission documents associated with nonclinical and bioanalytical studies (method validations and study sample analysis) conducted by BioMarin to evaluate regulatory compliance.
· Plan, conduct and report study-specific, process-based, CRO and internal BioMarin facility audits and inspections to assess compliance with GLP regulations and industry standards.
· Develop or revise departmental SOPs as requested.
· Lead role in supporting FDA and other regulatory inspections and requests during inspections. Procure Inspection Readiness documents/tools, organize inspection role playing and preparation activities as assigned. Assist in building eTools that support Inspection Readiness of GLP operations.
· Provide supervision, training and guidance to GLP Compliance personnel as directed by GLP Compliance Management.
· Assure departmental inspection reports and any other supporting documentation or required records are appropriately processed in the database and archives.
· Lead, plan, develop and document comprehensive GLP Training Program to BioMarin personnel involved in or supporting GLP activities.
· Identify regulatory compliance issues and provide regulatory support to the BioMarin regulated departments.
· Provide continued development and guidance of administration programs to promote and monitor the quality and performance of operations as they relate to both nonclinical and bioanalytical studies.
· Serve as a Team Leader with BioMarin Departments to support consistent practices and advice and represent GLP Compliance on appropriate BioMarin teams to facilitate inspection/audits planning and timely advice.
· Effectively interact and communicate with BioMarin employees in both intra- and inter-departmental settings.
· Keep Corporate Compliance & Ethics Management apprised of compliance and personnel issues through attendance at required meetings and frequent metrics reports.
· Initiates frequent communication with GLP Compliance Management to discuss timelines and critical regulatory issues.
· Lead Teams or individually manage departmental business, procedure, process, or general regulatory projects.
The Senior Assessment Manager will participate in GLP Compliance and QA activities which have a major impact BioMarin’s ability to make decisions on moving projects forward and overall drug development in the most compliant manner. In addition, the timely and accurate completion of all GLP Compliance tasks and projects directly impacts BioMarin’s ability to meet timelines for regulatory filings (domestic and international).
Minimum/Required: Bachelor’s (BS) in Life Science or closely related field of study.
· Experience in Biology, Chemistry, or applicable Life Science with a minimum of 8/12+ years related experience in GLP and GxP programs. Requires a BS degree in scientific discipline. At this level graduate (MS) coursework is desirable. Supervisory/management experience, actively participating in a GLP Quality Assurance/Compliance capacity and additional experience in GCP and/or GMP QA is a plus.
· Excellent background and understanding of GLP compliance and familiar with all aspects of FDA and other applicable international regulations. Excellent understanding of complex and evolving regulatory requirements and intent.
· Proven experience in conducting detailed external and internal audits.
· Excellent interpersonal and verbal/written communication skills.
· Highly motivated and detail oriented with proven organizational and leadership skills.
· Sound computer skills in word processing, spreadsheets and database software applications, specifically MS Office (Word, Excel, PowerPoint.)
· The ability to travel (~30%).
· RQAP-GLP, or other applicable, certification or registration, desirable.
· BioAnalytical Sciences (BAS) Management
· Pharmacology/Toxicology Study Monitors and Management
· Other Scientists and Research Associates (internal)
· Study Directors and Principal Investigators (BioMarin and CRO)
· Study Coordinators
· External Consultants
· Project Management and Regulatory Affairs
· BioMarin regulatory affairs, program management, research, quality (GxP), etc to provide the appropriate GLP Compliance expertise
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.