Senior Manager, GMP​/GDP Audit and Post Market Compliance

Senior Manager GMP/GDP Audit and Post Market Compliance

The Senior Manager GMP/GDP Audit and Post Market Compliance is a leadership role with responsibility and accountability for the governance, effectiveness, and continuous advancement of Bio Marin’s global Audit & Compliance programs across both internal and external sites. This role ensures sustained regulatory compliance, product quality, and patient safety, supporting and driving the global Audit and Compliance vision and strategy, and serving as a key advisor to the Senior Director Audit and Post Market Compliance.

• Establish and maintain a risk-based, fit‑for‑purpose GMP/GDP audit program aligned with Bio Marin’s Global Quality Management System (QMS) and global regulatory requirements.
• Generate and maintain the published annual internal and external audit plans and update the audit schedules quarterly to reflect evolving requirements.
• Triage new Audit Request Forms (ARF) and complete associated change control assessments.
• Develop and maintain metrics and management review processes to monitor audit program performance and appropriately elevate compliance risks.
• Manage 3rd‑party audit service providers, including processing of invoices, budget tracking, and SOW/contract management.

• Manage and continuously improve the Global Recall process and procedure.
• Execute the annual Mock recall in conjunction with Supply Chain, Bio Marin Qualified Person(s), and Responsible Person(s).
• Generate the Mock Recall Protocol and Report and present outcomes to leadership to ensure continued readiness across the business and supply chain networks.

• Manage and continuously improve the global Quality and Compliance escalation process through the Quality Review Board (QRB) process and procedure.
• Support the completion of the fact‑finding process to ensure timely and accurate communication of the issue, enabling effective decision‑making by Quality Leadership within prescribed Health Authority reporting timelines.
• Track assigned actions and archive completed escalations, and supporting documentation.
• Develop and maintain Health Authority reporting metrics for the Management Review process.

• Manage and continuously improve the GMP/GDP Emerging regulations program.
• Ensure timely assessment and triage of published GMP/GDP regulations and assign detailed assessments to identified TOPs subject matter experts.
• Track completion of assigned assessments to ensure compliance with published Health Authority requirements and timelines.
• Develop and maintain metrics for the Management Review process.
• Partner with the RDQ Emerging Regulations lead for a consistent approach to triage, assessment, and management of the Emerging Regulations Program.
• Interpret and advise TOPs functions on compliance requirements relating to newly published or adopted HA publications.

• Lead the digital advancement of the GMP/GDP Audit and Post Market Compliance programs by defining and executing a technology and data roadmap aligned with the broader Quality Digital Strategy.
• Leverage advanced analytics, automation, and AI‑enabled solutions to improve audit planning, execution, performance monitoring, risk identification, trend analysis, audit effectiveness, and decision‑making.
• Drive effective use of GMP/GDP Audit and Compliance data by integrating information from the QMS and external systems to generate actionable insights across both the internal and external network.
• Partner with IT, Quality Systems, and business stakeholders to implement sustainable, scalable digital and AI solutions that enhance GMP/GDP Audit and Post Market Compliance effectiveness and efficiency.
• Partner with IT and Quality Systems to deliver rolling Veeva enhancements related to the Veeva Audit module.

• Partner closely with External Quality, Manufacturing, Technical Development, Regulatory and other key stakeholders to ensure audit and compliance requirements are clearly…