Senior Manager, GMP/GDP Audit and Post Market Compliance

Establish and Maintain

• Develop and maintain a risk-based, fit-for-purpose GMP/GDP audit program aligned with BioMarin’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 escalate 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, BioMarin 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 Heath Authority requirements and timelines.
• Develop and maintain metric for the Management Review process.
• 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 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 closely with External Quality, Manufacturing, Technical Development, Regulatory and other key stakeholders to ensure audit and compliance requirements are clearly defined, aligned with business needs, and embedded across the program lifecycle.
• Collaborate with cross-functional teams to ensure documentation supporting the audit plan generation, recall program management, Quality Review Board (QRB) escalations, Emerging Regulations assessment etc., is robust, compliant, and fit for purpose.
• Represent GMP/GDP Audit and Post Market Compliance in cross-functional governance forums and during regulatory inspections and audits, as applicable.
• Function as the assigned BPO for the Global Recall process, GMP/GDP Audit program and the Quality Review forum for escalations reaching HA reporting thresholds.
• As BPO, drive a consistent, standardized approach while enabling flexibility where required.
• Foster a culture of quality, continuous improvement, innovation, and accountability within the team.
• Support the development, management, and monitoring of budgets and long-range plans for the GMP/GDP Audit and Post Market Compliance function.
• Manage APM services for outsourced 3rd Party audits to the GMP/GDP audit team.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline required.
• Advanced degree (MS, PhD, MBA) desirable but not required.
• Six Sigma or Lean certification desirable.
• Minimum of 10 years of experience in Quality Assurance, Regulatory, Manufacturing, or related roles within a highly regulated industry (biotechnology, pharmaceutical, medical device, or combination products).
• In-depth knowledge of global quality and regulatory requirements (e.g., GMP, GDP, ISO standards, 21 CFRs).
• Demonstrated experience in audit and compliance program management and supporting complex, virtual external supply chain networks.
• Strong experience operating in a matrix, global environment and influencing without direct authority.
• Demonstrated experience using data, analytics, and digital tools to improve quality outcomes; experience with AI-enabled solutions a strong plus.
• Excellent communication, collaboration, and stakeholder management skills, including interaction with senior leadership and regulators.