Principal Assessment Manager, GLP ComplianceLocation San Rafael, California Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. 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 unique issues that impact design/selling success or address future concepts, products or technologies. Creates formal networks with key decision makers and serves as external spokesperson for the organization.
- Exercises wide latitude in determining objectives and approaches to critical assignments.
- 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 & Ethic 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 Principal 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).
- Experience in Biology, Chemistry, or applicable Life Science with a minimum of 12/15+ years related experience in GLP and GxP programs. Requires a BS degree in scientific discipline. At this level a post-graduate (PhD) coursework may be expected. 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.
Work Environment/Physical Demands:
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Speech clarity, utilization of fingers and hands, standing-remaining on one’s feet in an upright position, sitting-remaining in the normal seated position, holding, grasping.
- The incumbent may frequently be required to sit, work on a computer, talk on the phone and/or hear.
- Possible exposure to infection from disease-bearing specimens or radiation; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.
- Far acuity-ability to see clearly at 20 feet or more; near acuity-ability to see clearly at 20 inches or less; depth perception-ability to judge distance and space relationships; color vision-ability to distinguish and identify different colors.
Position involves up to 30% travel to monitor studies and attend training and conferences.
As an Auditor, may be exposed to hospital and veterinary facilities in the course of a study audit. Employee should have a current immunization record; the employee may be required to have a TB skin test (PPD-Mantoux) every six months or if the TB skin test is ‘Positive’ a chest X-ray will be required every twelve months.
- Windows network environment, MS Word, MS Excel, MS PowerPoint
- Managers BioAnalytical Sciences (BAS)
- 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, manufacturing, quality (GxP), etc to provide the appropriate GLP Compliance expertise