Key Facts

Remote From:

United States

Full time

Senior (5-10 years)

English

Hard Skills

Other Skills

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Communication
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Leadership
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Strategic Thinking
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Coaching

BioMarin Pharmaceutical Inc.

Research

About BioMarin Pharmaceutical Inc.

Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact. Recruitment Fraud Alert Notice 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. 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. 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. We appreciate your interest in BioMarin & encourage you to visit http://careers.biomarin.com/career-areas to review job opportunities.

Company type: Large

Industry: Research

Founded: 2018

Company size: 1001 - 5000

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Job description

Description

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

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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.

SUMMARY DESCRIPTION

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 organization and Technical Operations. The DG/DI program has established a strong foundation and now requires focused maturation — 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.

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 — including AI/ML validation frameworks, EU GMP Annex 11, and Computer Software Assurance — 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 — reducing cost and inefficiency while building long-term organizational capability and regulatory resilience.

RESPONSIBILITIES

DG/DI Program – Quality Assurance Oversight & Program Enhancemen

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.
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.
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.
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.
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.
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.
Own the DG/DI QMS SOPs and supporting procedures; ensure harmonization and alignment across the QMS hierarchy and consistent application of DI requirements enterprise wide.
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.

Enterprise Computerized System CSV/CSA – Quality Assurance Project Support

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 — partnering with IT, system owners, and project teams who execute.
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.
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.
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.
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.
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.

QUALIFICATIONS

Required

Bachelor’s degree in Life Sciences, Engineering, Computer Science, or a related field; advanced degree preferred.
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.
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.
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.
Experience with systems modernization programs, cloud and SaaS validation strategies, and application of CSA principles to emerging technology platforms.
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.
Demonstrated experience leading cross-functional DG/DI or CSV/CSA governance bodies, quality forums, or enterprise working groups; able to operate effectively at the program strategy level and influence senior stakeholders without direct authority.
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.
Strong understanding of electronic QMS platforms (e.g., Veeva Vault) and how DI principles are embedded throughout quality systems.
Excellent communication skills with demonstrated ability to influence cross-functionally without direct reporting authority in a matrixed environment.
Experience participating in health authority inspections as a CSV/CSA or DI subject matter expert.

Preferred

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.
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.
Proficiency with data visualization and QMS analytics tools (e.g., Power BI, Veeva reporting).
ISPE GAMP, ASQ or equivalent professional certification in Data Governance or CSV/CSA disciplines.
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.

Workstyle:

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

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.