We are seeking an experienced Information Governance Lead to join our IT organization and drive the strategic direction of information governance across the enterprise.
Responsibilities
Strategy & Roadmap
- Define and operationalize the enterprise Information Governance operating model, including central versus federated roles, decision rights, escalation paths, and determining whether a governance council is required.
- Develop and own a multi‑year strategic roadmap aligned to security and compliance risk management, information findability, and AI enablement.
- Translate business needs and regulatory requirements into actionable governance initiatives with clearly defined milestones, KPIs, and success metrics.
- Present governance strategy, progress, and risk posture to IT leadership, the CISO, and cross‑functional steering committees on a regular cadence.
- Monitor evolving regulatory landscapes (e.g., FDA 21 CFR Part 11, EU Annex11, GDPR, HIPAA) and adjust the roadmap accordingly.
Security & Compliance Risk Management
- Partner with Information Security to define and enforce data classification, labeling, and handling policies for regulated and sensitive pharmaceutical data.
- Establish and oversee information lifecycle management practices, including retention schedules, legal hold procedures, and defensible disposition protocols.
- Conduct periodic risk assessments and collaborate with Compliance and Legal to remediate identified gaps.
- Ensure governance controls align with GxP requirements and support audit readiness across clinical, manufacturing, and commercial data domains.
- Lead responses to internal audits, regulatory inspections, and third‑party assessments related to information governance.
Information Findability
- Define and implement enterprise‑wide taxonomy, metadata standards, and content architecture to improve search, discovery, and reuse of information assets.
- Evaluate and recommend technologies (enterprise search, content management, knowledge graphs) that enhance findability.
- Work with business units to establish content stewardship roles and ensure ongoing data quality and metadata enrichment.
- Develop training and change‑management initiatives to drive adoption of governance standards and tools.
AI Enablement
- Establish governance guardrails that enable the responsible use of AI and large language models across the organization, including data quality, provenance, and ethical use policies.
- Collaborate with Data Science, IT Architecture, and business teams to ensure AI training datasets meet governance and quality standards.
- Define metadata and lineage requirements to support explainability, traceability, and reproducibility of AI‑driven insights.
- Contribute to the enterprise AI governance framework, including acceptable use policies, model risk management, and human‑in‑the‑loop review processes.
Cross‑Functional Leadership & Stakeholder Engagement
- Serve as the primary point of contact for information governance across IT, Information Security, Legal, Compliance, R&D, Commercial, and Manufacturing.
- Build and lead a network of information stewards and champions embedded within business functions.
- Manage vendor relationships related to governance tooling and platforms, including contract reviews and capability assessments.
- Assess resource and capability needs over time and recommend when additional Information Governance roles are warranted.
Qualifications
- 8+ years of progressive experience in information governance, data governance, records management, or a related discipline, with at least 3 years in a leadership or principal‑level capacity.
- Experience in a regulated industry, preferably pharmaceuticals, biotechnology, or life sciences.
- Deep understanding of information lifecycle management, data classification, metadata management, and content architecture.
- Strong knowledge of pharmaceutical regulatory requirements (e.g., FDA 21 CFR Part11, EU Annex11, GxP, GDPR, HIPAA).
- Hands‑on experience with enterprise content management platforms (e.g., SharePoint, OpenText, Veeva Vault) and enterprise search technologies.
- Experience partnering with Information Security on data protection, access controls, and DLP strategies.
- Familiarity with AI/ML concepts, retrieval‑augmented generation (RAG), and the governance implications of large language models.
- Experience implementing or managing information governance tooling such as MicrosoftPurview, Atlan, Collibra, or equivalent platforms.
- Track record of establishing governance operating models, including stewardship networks and data councils.
- Experience with cloud information governance across platforms such as AWS and/or Azure.
- Excellent communication, influencing, and stakeholder‑management skills.
- Strong analytical and systematic problem‑solving abilities.
- Educational qualifications: Bachelor’s degree in Information Science, Computer Science, Library Science, Data Management, Business Administration, or a related field (required). Master’s degree (preferred).
- Preferred certifications: Certified Information Governance Professional (IGP), Certified Records Manager (CRM), CDMP, CIPP/US or CIPP/E, CISSP, CISM, ITIL Foundation.
Compensation and Benefits
- Salary range: $186,489 – $278,875 plus incentive opportunities.
- Comprehensive medical, dental, vision, and disability insurance; 401(k) match; paid holidays and flexible time off.
- Additional benefits: tuition reimbursement, student loan assistance, and other corporate offerings.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.
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