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 BioMarin’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 BioMarin’s long-term business and quality strategy.

RESPONSIBILITIES

Audit Program Management Establish 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 elevate compliance risks appropriately. Manage 3rd party audit service providers including processing of invoices, budget tracking, and SOW/contract management. Recall Business Process Owner (BPO) 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. Quality Review Board Business Process Owner 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. Emerging Regulations and Market Intelligence 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. Digital Transformation, Data & Artificial Intelligence 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. Cross-Functional & Network Collaboration 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. Leadership, Talent & Organization Development 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. Financial & Business Management 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.

EDUCATION

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.

EXPERIENCE

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. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #J-18808-Ljbffr Initial Therapeutics, Inc.