The PositionThe Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle. This role is accountable for governance, validation strategy, inspection readiness, and compliant system administration, ensuring alignment with global regulatory requirements (FDA, EMA, MHRA, ICH) and evolving industry standards (GAMP 5, CSA).
This leader serves as a key partner to Manufacturing, Quality, CMC, CSA and Compliance, GLP Operations, and external vendors, driving scalable compliance frameworks while enabling business agility. The role combines system ownership and administration, validation project management, and organizational oversight to ensure enterprise-wide data integrity and computerized system compliance.
Responsibilities
Strategic Leadership & Governance- Maintain governance frameworks for GxP computerized systems
- Define validation strategies aligned with GAMP 5 and CSA principles
- Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition)
- Serve as system owner and system administrator for critical GxP platforms
- Maintain validation and system lifecycle policies and standards
- Participates in continuous improvement of validation methodologies, templates, and risk-based approaches
- Provide compliance guidance to executive leadership and functional heads
System Lifecycle Oversight- Oversee administration and compliant operation of GxP systems (Laboratory systems, LIMS, MES, EDMS, enterprise SaaS platforms)
- Ensure systems remain validated, secure, and audit-ready throughout implementation, upgrades, and decommissioning
- Approve system configurations, changes, and access governance frameworks
- Ensure robust data integrity controls in accordance with ALCOA+ principles
- Monitor system performance, audit trails, cybersecurity controls, and vendor compliance
Validation Program Leadership- Lead enterprise validation initiatives across multiple concurrent projects
- Oversee development and approval of validation deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability, Summary Reports)
- Ensure appropriate application of risk-based validation and CSA methodologies
- Manage validation master planning and resource allocation
- Provide oversight of regression testing and revalidation strategies
- Ensure validation documentation supports global inspection readiness
- Act as SME during regulatory inspections and internal audits
- Oversee remediation efforts related to audit findings, deviations, and CAPAs
- Maintain awareness of evolving global regulatory expectations
Project & Vendor Management- Lead cross-functional teams across CMC, Quality, IS&I, Manufacturing, Engineering, GLP Operations, and external partners
- Oversee third-party vendors and validation consultants
- Manage budgets, timelines, risks, and resource planning for validation programs
- Drive issue resolution and escalation management
- Ensure vendor deliverables meet compliance and quality standards
People & Organizational Development- Lead, mentor, and develop validation and system administration staff
- Establish performance expectations and competency development plans
- Build scalable team capabilities to support business growth
Requirements- Bachelor's degree in Life Sciences, Engineering, IT, or related discipline (advanced degree preferred)
- 8+ years of experience in GxP computerized systems and validation
- 3+ years in a leadership or program management role
- Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, and global data integrity requirements
- Demonstrated experience leading complex, enterprise-level system implementations
- Strong understanding of change control, deviation management, CAPA, and quality systems
- Proven ability to influence senior stakeholders and drive cross-functional alignment
Preferred- PMP or equivalent project management certification
- GAMP, ITIL, or related compliance certification
- Experience leading CSA transformation initiatives
- Extensive experience related to administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson)
- Pharmaceutical or CRO experience
- Prior regulatory inspection leadership experience
- Risk-based decision making
- Continuous improvement mindset
Wisconsin pay range
$145,000-$165,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
