Senior Manager, Data Governance & Data Integrity, Computer System Validation Program

b'nnnnnnnn Senior Manager, Data Governance & Data Integrity, Computer System Validation Program | BioMarin Corporatennnn n n nnntntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnnn nn

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Senior Manager, Data Governance & Data Integrity, Computer System Validation Program

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Location: United States

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Workstyle: Remote Only

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Senior Manager, Data Governance & Data Integrity, Computer System Validation Program for Quality

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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

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The Senior Manager, Data Governance & Data Integrity (DG/DI) and CSV/CSA Program will own and advance two critical, interdependent quality programs that underpin enterprise regulatory compliance and operational excellence within the global Quality organizationxc2xa0and Technical Operations. The DG/DI program has established a strong foundation and now requires focused maturation xe2x80x94 building program depth through defined KPIs, metrics, and maturity assessments; continuously strengthening alignment with evolving global regulatory requirements; and integrating emerging technology considerations such as AI/ML data integrity requirements into the QMS. The CSV/CSA program is an established enterprise function but is fragmented across the business, creating cost inefficiencies and inconsistency in execution; this role will drive harmonization of the CSV/CSA framework to achieve a unified, risk-based approach across all sites and functions.

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The ideal candidate possesses deep expertise in data integrity, data governance, and GxP computerized system validation, with a demonstrated ability to mature and harmonize programs across a complex, multi-site enterprise. They bring strong command of evolving global regulatory expectations xe2x80x94 including AI/ML validation frameworks, EU GMP Annex 11, and Computer Software Assurance xe2x80x94 and can translate those requirements into practical program enhancements that keep the organization ahead of the compliance curve. The ideal candidate will assess program maturity, define meaningful KPIs and metrics, and identify gaps and priorities that drive continuous improvement across both disciplines. In this role, you will serve as the enterprise subject matter expert and the central force for elevating DG/DI program maturity and unifying a fragmented CSV/CSA landscape xe2x80x94 reducing cost and inefficiency while building long-term organizational capability and regulatory resilience.

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RESPONSIBILITIES

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DG/DI Program xe2x80x93 Quality Assurance Oversight & Program Enhancement

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• Serve as the enterprise subject matter expert for data integrity, data lifecycle management, ALCOA+ principles, and GxP data governance frameworks (FDA, EMA, MHRA, WHO, PIC/S); define program strategy, KPIs, and maturity assessments to drive measurable and sustained DG/DI program enhancement. n
• Lead the integration of Data Integrity by Design (DI by Design) principles into QMS processes, procedures, and system design; establish program maturity benchmarks and track enterprise-wide progress against defined targets. n
• Support site and function DI gap assessments and remediation strategy; identify compliance risks, drive visibility and resolution with DI Leads and site management, and provide expert technical guidance and direction. n
• Design the enterprise DG/DI training model and co-develop role-based curricula in partnership with global and site training coordinators and DI Leads, building sustained data integrity capability across the organization. n
• Lead the DG/DI Governance Program and Quality Plan; ensure DI Leads maintain progress against commitments, escalate issues to executive management, and present program status, risk landscape, and key metrics at Quality Management and Quality System review forums. n
• Serve as the primary DG/DI subject matter expert for internal and external audits and regulatory inspections; prepare supporting documentation, respond to findings, and ensure remediation is tracked to closure. n
• Own the DG/DI QMS SOPs and supporting procedures; ensure harmonization and alignment across the QMS hierarchy and consistent application of DI requirementsxc2xa0enterprise wide. n
• Monitor and translate emerging regulatory requirements (EU GMP Annex 11 revised, Annex 22, Chapter 4, AI/ML DI frameworks, FAIR data principles) into actionable QMS and program updates; cultivate strong partnerships with IT, CSV leads, DI Leads, BPOs, and system owners to secure alignment and ensure sustained adoption. n

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Enterprise Computerized System CSV/CSA xe2x80x93 Quality Assurance Project Support

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• Provide QA oversight and strategic direction for enterprise computerized system CSV/CSA programs; define validation strategy, GxP applicability determinations, and risk-based approaches across the full system lifecycle xe2x80x94 partnering with IT, system owners, and project teams who execute. n
• Drive harmonization of a fragmented enterprise CSV/CSA landscape; establish a unified, risk-based framework aligned with FDA CSA guidance and GAMP 5 that eliminates redundancy, reduces cost, and improves consistency across sites and functions. n
• Review and approve CSV/CSA deliverables including validation strategy, GxP applicability assessments, URS, risk assessments, traceability matrices, test protocols, and validation summary reports; translate regulatory requirements into practical QMS and project-level requirements. n
• Provide QA guidance on changes to validated computerized systems; assess scope and impact, determine appropriate validation or re-validation requirements, and maintain oversight of the enterprise validated systems inventory. n
• Develop and maintain the CSV/CSA program KPI framework, providing DI Leads, system owners, and management with meaningful visibility into program performance and areas requiring attention; champion integration of AI/ML and cloud/SaaS considerations into the CSV/CSA quality framework. n
• Serve as the primary CSV/CSA QA resource for internal and external audits and regulatory inspections; ensure program documentation supports inspection readiness and partner with project teams to resolve findings. n

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QUALIFICATIONS

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Required

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• Bachelorxe2x80x99s degree in Life Sciences, Engineering, Computer Science, or a related field; advanced degree preferred. n
• 10+ years of progressive experience in a GxP-regulated pharmaceutical, biotechnology, or life sciences environment, with a clear track record of increasing program ownership and scope. n
• Proven track record of leading and establishing enterprise DG/DI governance programs and/or QMS data integrity requirements from the ground up or through significant maturation; candidates with only site-level or execution-focused DI experience will not be considered. n
• Extensive experience in GxP computerized system lifecycle management (CS LCM) spanning manufacturing systems (MES, SCADA, DCS, automation), Quality and Clinical Quality systems (QMS, LIMS), and enterprise platforms. n
• Experience with systems modernization programs, cloud and SaaS validation strategies, and application of CSA principles to emerging technology platforms. n
• Deep working knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ALCOA+ principles, ISPE Good Practice Guides, ICH Q9/Q10, and FDA/MHRA/EMA/WHO data integrity guidance; working knowledge of emerging requirements including Annex 11 (revised draft), Annex 22, Chapter 4, and AI/ML validation frameworks. n
• Demonstrated experience leading cross-functional DG/DI or CSV/CSA governance bodies, quality forums, or enterprise working groups; able to operate effectively atxc2xa0the program strategy level and influence senior stakeholders without direct authority. n
• Proven ability to lead enterprise or multi-site DG/DI programs at the governance and strategy level, including program design, QMS SOP ownership, maturity assessments, KPI frameworks, and regulatory inspection support as a subject matter expert. n
• Strong understanding of electronic QMS platforms (e.g., Veeva Vault) and how DI principles are embedded throughout quality systems. n
• Excellent communication skills with demonstrated ability to influence cross-functionally without direct reporting authority in a matrixed environment. n
• Experience participating in health authority inspections as a CSV/CSA or DI subject matter expert. n

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Preferred

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• Working knowledge of AI/ML model validation, data integrity requirements for AI-enabled GxP systems, and application of emerging FDA/IMDRF AI/ML frameworks to Quality and manufacturing contexts. n
• Background in data lifecycle management and FAIR data principles as applied to GxP environments, experience with enterprise data governance platforms and electronic records management strategies. n
• Proficiency with data visualization and QMS analytics tools (e.g., Power BI, Veeva reporting). n
• ISPE GAMP, ASQ or equivalent professional certification in Data Governance or CSV/CSA disciplines. n
• 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. n

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Workstyle:

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• This is a virtual position unless you live within 100 miles of Novato, Ca (zip code 94903).xc2xa0 If so, then the role reverts to hybrid requiring being onsite twice a week. n

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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: $137,600 to $189,200. 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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