Job Description
Job Description:Title: Associate Director - Good Pharmacovigilance Practices (GVP) / Drug Safety Location: Remote Travel: Up to 40% domestic and international\u00A0About BioMarin\u00A0BioMarin is a leading biopharmaceutical company with over 25 years of experience in developing life-changing therapies for patients with rare genetic diseases. 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.Why Join Us? Make a meaningful impact on patients' lives Be part of an inclusive and diverse company culture Enjoy a flexible and friendly work environment Develop long-term career growth opportunities Competitive salary and benefits package\u00A0Role OverviewWe are seeking a highly experienced AD for Good Pharmacovigilance Practices (GVP) and Drug Safety to lead third-party and internal audits, ensuring compliance with global pharmacovigilance standards.Key Responsibilities Lead internal and external risk-based audits Drive risk-based audit schedule Conduct pre-audit meetings with internal stakeholders Define the audit agenda, identifying and focusing on high-risk areas Execute audits and manage associated administrative tasks Prepare and distribute audit reports, ensuring timely communication with auditees and stakeholders Assist in identifying compliance gaps and coordinate CAPA remediation efforts Serve as a subject matter expert for GVP audits, providing researched, fact-supported information on complex issues Collaborate with cross-functional partners to build relationships and identify audit needs Maintain performance metrics in alignment with departmental KPIs Maintain current expertise in the field Other duties as assigned\u00A0Requirements Bachelor's Degree in life sciences; Advanced Degree (Masters) in a scientific discipline preferred 10 years of experience within the regulated healthcare industry, with extensive knowledge of global GVP regulations Auditor certification preferred, e.g., ASQ Working knowledge of FDA Drug Safety Regulations and EMA GVP, with an understanding of their practical application Strong verbal, written, and oral communication skills; able to present audit and compliance information to senior management Ability to work independently and adjust to changing priorities Proficient in computer skills, including word processing, spreadsheets, and presentationsApplication ProcessTo apply for this position, please submit your resume and a cover letter detailing your relevant experience and interest in the role.Work EnvironmentThis position will be based remotely. Travel to San Rafael, California (Headquarters) is expected annually, at minimum, to engage in meetings with Team Members, Senior Leadership and Stakeholders as necessary.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.
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