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.

The Senior Manager supports and drives the global Audit and Compliance vision and strategy and is a key advisor to the Senior Director Audit and Post Market Compliance. This includes audit program management, auditing, inspection readiness, recall coordination, global issue management and escalation through the QRB and triage of emerging GMP/GDP regulations. The role interfaces with teams and other leaders across TOPs to detect and mitigate quality & compliance risk, drive escalation processes, and embed a consistent, risk-based approach across the global network.

As a key change leader within Quality, the Senior Manager is also accountable for advancing digital and data-enabled Audit and Compliance capabilities, including the adoption of automation, advanced analytics, and artificial intelligence (AI). Through these capabilities, the role ensures proactive risk identification, data-driven decision-making, and scalable oversight aligned with Bio Marin’s long-term business and quality strategy.

• 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 elevate compliance risks appropriately.
• 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 state of 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 thereby 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 metric 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 (SMEs), as applicable.
• Track completion of assigned assessments to ensure compliance with published Health Authority requirements and timelines.
• Partner with the RDQ Emerging Regulations lead to ensure a consistent approach to the triage, assessment and management of the Emerging Regs Program.
• Interpret and advise TOPs functions on the 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…