Senior Manager, GMP/GDP Audit and Post Market Compliance

b'nnnnnnnn Senior Manager, GMP/GDP Audit and Post Market Compliance | BioMarin Corporatennnn n n nnntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnnn nn

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n BioMarin Pharmaceuticaln

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Senior Manager, GMP/GDP Audit and Post Market Compliance

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Location: Novato, United States

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Workstyle: Hybrid

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Who We Are

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BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

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Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

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About Technical Operations

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BioMarinxe2x80x99s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarinxe2x80x99s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

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SUMMARY DESCRIPTION

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 BioMarinxe2x80x99s 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 BioMarinxe2x80x99s long-term business and quality strategy.

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This position requires deep GxP expertise, a strong presence, and the ability to operate with authority and influence in a complex, global, matrixed organization.

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RESPONSIBILITIES

Audit Program Management

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• Establish and maintain a risk-based, fit-for-purpose GMP/GDP audit program aligned with BioMarinxe2x80x99s Global Quality Management System (QMS) and global regulatory requirements. n

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• Generate and maintain the published annual internal and external audit plans and update the Audit schedules quarterly to reflect evolving requirements. n

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• Triage new Audit Request Forms (ARF) and complete associated change control assessments. n
• Develop and maintain metrics, and management review processes to monitor Audit program performance and escalate compliance risks appropriately. n
• Manage 3rd party audit service providers including processing of invoices, budget tracking, and SOW/contract management. n

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Recall Business Process Owner (BPO)

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• Manage, and continuously improve, the Global Recall process and procedure. n
• Execute the annual Mock recall in conjunction with Supply Chain, BioMarin Qualified Person(s) and Responsible Person(s). n
• 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. n

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Quality Review Board Business Process Owner

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• Manage, and continuously improve the global Quality and Compliance escalation process through the Quality Review Board (QRB) process and procedure. n
• 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. n
• Track assigned actions and archive completed escalations, and supporting documentation. n
• Develop and maintain Health Authority reporting metric for the Management Review process. n

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Emerging Regulations and Market Intelligence

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• Manage and continuously improve the GMP/GDP Emerging regulations program. n
• Ensure timely assessment and triage of published GMP/GDP regulations and assign detailed assessments to identified TOPs subject matter experts (SMEs), as applicable. n
• Track completion of assigned assessments to ensure compliance with published Heath Authority requirements and timelines. n

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• Develop and maintain metric for the Management Review process. n

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• Partner with the RDQ Emerging Regulations lead to ensure a consistent approach to the triage, assessment and management of the Emerging Regs Program. n
• Interpret and advise TOPs functions on the compliance requirements relating to newly published or adopted HA publications. n

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Digital Transformation, Data & Artificial Intelligence

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• 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. n
• Leverage advanced analytics, automation, and AI-enabled solutions to improve audit planning, execution, performance monitoring, risk identification, trend analysis, audit effectiveness, and decision-making. n
• 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. n
• 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. n
• Partner with IT and Quality Systems to deliver rolling Veeva enhancements, related to the Veeva Audit module. n

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Cross-Functional & Network Collaboration

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• 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. n
• 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. n
• Represent GMP/GDP Audit and Post Market Compliance in cross-functional governance forums and during regulatory inspections and audits, as applicable. n

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Leadership, Talent & Organization Development

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• 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. n
• As BPO, drive a consistent, standardized approach while enabling flexibility where required. n
• Foster a culture of quality, continuous improvement, innovation, and accountability within the team. n

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Financial & Business Management

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• Support the development, management, and monitoring of budgets and long-range plans for the GMP/GDP Audit and Post Market Compliance function. n
• Manage APM services for outsourced 3rd Party audits to the GMP/GDP audit team. n

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EDUCATION

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• Bachelorxe2x80x99s degree in Life Sciences, Engineering, or a related discipline required. n
• Advanced degree (MS, PhD, MBA) desirable but not required. n
• Six Sigma or Lean certification desirable. n

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EXPERIENCE

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• 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). n
• In-depth knowledge of global quality and regulatory requirements (e.g., GMP, GDP, ISO standards, 21 CFRs). n
• Demonstrated experience in audit and compliance program management and supporting complex, virtual external supply chain networks. n
• Strong experience operating in a matrix, global environment and influencing without direct authority. n
• Demonstrated experience using data, analytics, and digital tools to improve quality outcomes; experience with AI-enabled solutions a strong plus. n
• Excellent communication, collaboration, and stakeholder management skills, including interaction with senior leadership and regulators. n

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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.

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Equal Opportunity Employer/Veterans/Disabled

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An 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.

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The salary range for this position is: $143,200 to $196,900. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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Recruitment Fraud Alert Notice

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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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Equal Opportunity Employer/Veterans/Disabled

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An 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.

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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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