Senior Manager, GMP/GDP Audit and Post Market Compliance
Description
Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people’s 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.
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.
About Technical Operations
BioMarin’s 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 BioMarin’s 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.
- 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 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 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 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.
- 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.
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/Veterans/Disabled
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.