Manager, GxP Compliance

Location:  Novato, California Category: Compliance


Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Manager, GxP Compliance

We are looking for an individual with experience working in R&D Quality and Compliance, with prior exposure to supporting R&D Audit Operations.  Experience in Pharmacovigilance (PV) audits and/or PV/drug safety quality operations is desired, however, any combination of GVP/GCP/GLP audit exposure will be considered.  This important role will join our Worldwide Research and Development (WWRD) Quality Compliance team within the BioMarin Quality organization.
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, clear communication, effective collaboration, critical thinking and organization/time management are essential role requirements.  
This Manager level role acts as a core team member within the WWRD GxP Audit Program interfacing with internal auditors, consultants, leadership, auditees across the globe, and will become a superuser within the Audit Management System – eQMS.  Prior experience as an auditor or desire to develop into a PV auditor would be an additional area of expertise desired.  Being comfortable reviewing global regulations, assessing ongoing compliance with company standards, and providing guidance on post audit execution including implementation of Corrective and Preventive actions (CAPAs) to address deficiencies is required.  
All employees are required to follow defined processes and policies and behave in a professional manner with integrity.
Detailed Responsibilities:
This Manager Level role will support the execution of the WWRD GxP Audit Program with heightened focus in pharmacovigilance audit related responsibilities.

Primary Responsibilities
-Participate in audit planning including internal or external audit risk assessment, audit scheduling, development of audit scope/agenda, and managing pre-audit meetings
-Host and manage internal audits independently or in support of assigned lead auditor 
-Perform external audits independently or under the guidance of an assigned lead auditor
-Management of post audit finding responses with internal and external auditees
-CAPA Governance Lead responsible for tracking/managing corrective and preventative actions (CAPAs) to completion and review of CAPA evidence to ensure on-time closure of audit records in the eQMS
-Participate in management and presentation of audit metrics 
-Participate in due diligence activities and process improvement initiatives, as requested
-Support in development and/or enhancements to WWRD Quality Compliance business processes, procedures and best practices
-Participate in regular Pharmacovigilance System Master File (PSMF) updates to support audit and CAPA status reporting
-Support readiness and preparation activities for WWRD GxP inspections

Technical Skills Required
-Effectively communicate audit outcomes with internal and external stakeholders
-Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation
-Assessment of whether finding responses meet regulatory authority, local authority, and BioMarin requirements 
-Partner within GxP Compliance and cross-functional departments regularly i.e., Pharmacovigilance Operations, Regulatory Affairs, Global Medical Affairs, Global Study Operations and Commercial to obtain regulatory intelligence, business risk area guidance, and consultation to anticipate upcoming auditing needs
Bachelor’s Degree within a life science focus area
-Working knowledge of FDA Regulations, EMA and application of Good Pharmacovigilance Practices (GVP), and/or ICH, GCP and GLP regulations
-5+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
-Ideal candidate will have exposure to working in any phase of pharmaceutical drug development or post-marketing surveillance of medicines
-Strong verbal, written and oral communication skills.  Able to present to Senior Management
-Able to work independently and be flexible to changing priorities
-Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems
Work Environment/Physical Demands
May travel up to 20% of the time.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.