Job Description
About BioMarinBioMarin is a global, high-performing, team-based organization, where colleagues are flexible, multi-skilled, and empowered to make decisions. Our mission is to transform lives through genetic discovery, and we are dedicated to fostering an inclusive and diverse culture where employees feel valued and can thrive. BioMarin's GXP Compliance function partners with business stakeholders to actively identify and mitigate compliance risk, exemplifying innovation powered by integrity. Why Join BioMarin's Compliance Department?Make a meaningful impact on patients' livesBe part of an inclusive and diverse company cultureEnjoy a flexible and friendly work environmentDevelop long-term career growth opportunitiesCompetitive salary and benefits packageRole OverviewWe are seeking a highly experienced Senior Manager, GxP Compliance Audit to play a key role in executing BioMarin’s GCP/GLP/GVP Audit Program. This position ensures continuous compliance with applicable global regulations and BioMarin standards through periodic assessments of internal and external operations. Key ResponsibilitiesPrepare and lead complex audits across GLP and GCP operations, including internal BioMarin sites and third parties (domestic and international)Conduct GCLP audits of non-clinical and clinical study reports, central and specialty laboratories (CLIA and CAP)Lead pre-audit meetings with internal stakeholders to determine current vendor status and review pre-audit documentationExecution of auditsPrepare and distribute audit reportsAssist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediationLead audit debrief meetings with internal and external stakeholders to communicate audit outcomesEscalate issues of critical noncompliance and coordinate/lead remediation effortsManage audit responses, including assessing whether response meets regulatory authority, local authority, and BioMarin requirementsTrack and manage corrective and preventative actions (CAPAs) to completion and review for effectiveness as necessaryMaintain performance metrics in alignment with KPIsSupport GxP audit program as requiredOther duties as assignedRequirementsBachelor’s Degree with a life science focus, Advanced Degree (Masters) in a scientific discipline a plusExtensive knowledge of GCP/GLP regulations with 10 years of experience within a regulated healthcare industryProfessional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality – Certified Quality Auditor)Working knowledge of FDA Regulations, EU GLP, and local country regulationsStrong verbal, written, and oral communication skills, able to present business indicators to Senior ManagementAble to work independently and be flexible to changing prioritiesApplication ProcessTo apply for this position, please submit your resume and a cover letter detailing your relevant experience and interest in the role. [Include any additional application instructions or deadlines if applicable.]BioMarin is 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.
