Sr. Manager, GxP Compliance Audit (Pharmacovigilance)
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.
The BioMarin GxP Compliance function is tasked with providing independent assurance services designed to enhance scientific innovation with effective risk management. The GxP Compliance team partners with the business to strengthen the commitment to compliance by advising cross-functional teams through the Strategy subfunction, identifying and mitigating risk through the Audit subfunction, and leading distribution and proactive compliance through the Operations subfunction.
Within GxP Compliance, the Audit subfunction is responsible for maintaining adherence to industry regulations through independent, risk-based assessments. The team leads multiple audit types internally and with domestic and international third parties, including but not limited to suppliers, contract manufacturers, contract laboratories, commercial distribution partners and key PV service providers.
The Sr. Manager, (PV Audit) is responsible for the planning and execution of audits to assess ongoing compliance with regulations and corporate standards. This position will have primary responsibility for leading or coordinating multiple audit types for GVP compliance. This includes oversight of both internal global sites and external service providers managing PV activities (e.g. SP, PSP, REMS, aRMM/RMP, Signal Detection). The variety of service providers, both internal and external, may require up to 50% global travel when conducting audits on-site versus remotely or virtually. The Sr. Manager (PV Audit) will contribute to the qualification and training of PV auditors
The Sr. Audit Lead typically leads critical and complex third-party audits and internal audits based on a combination of experience and technical expertise.
Audit Planning and Execution
- Prepare and lead audits across multiple internal sites and third parties both domestic and international, including:
- Ability to travel up to 50% of the time and accommodate time zone differences for remote audits
- Lead audit scheduling and prioritization
- Coordinate consultant-led PV audits
- Lead pre-audit meeting with internal stakeholders to determine current audit status and review pre-audit documentation
- Define the audit agenda, focusing on high-risk areas
- Execute the audit, including traveling to the site and associated administrative tasks
- Prepare audit report in Trackwise, including internal and external reports
- Escalate critical non-compliances /potential risks to internal management and stakeholders
- Debrief internal and external stakeholders
- Manage audit responses, including assessing whether response meets regulatory authority, local authority, and BioMarin requirements
- Track and manage corrective and preventative actions (CAPAs) to completion.
- Serve as subject matter expert for PV audits, providing researched and fact-supported information and opinions often on complex issues that lack precedence.
- Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation.
- Work closely with Group Heads to manage current issues and anticipate upcoming auditing needs outside of assigned programs
- Contribute as a scribe or subject matter expert during regulatory inspections, as needed
- Participate in Operational Excellence initiatives that may include creation and implementation of new business process
Team Support and Engagement
- Participate in process-improvement initiatives
- Present on areas of GVP expertise
- Participate in the ongoing training and development of Auditors
The Senior Manager is a subject matter expert and is an individual contributor with their primary role on department-level operations.
- Breaks down complex and ambiguous problems into manageable components for investigation and applies logic to problem definition
- Develops and delivers well organized and effective presentations to any level of the organization
- Comprehensive knowledge of global regulations and guidance in one or more GxP areas of focus; outside of primary focus area, holds basic familiarity with regulations in one or more additional GxP areas
- Leverages a comprehensive understanding of critical data, data sources and trends analysis to identify areas of highest risk
- Familiar with risk management concerns and prospective challenges associated with each stage of the product lifecycle
- BA/BS degree with a focus on life sciences or a related scientific or technical discipline
- 12 or more years of experience in the biotechnology, pharmaceuticals, or medical products industries in a pharmacovigilance supporting role, to include 5+ years of audit experience
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.