IT GxP Compliance Director / SME Consultant

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IT GxP Compliance Director / SME Consultant

Waltham, MA-onsite

Position Summary:

We are seeking an experienced IT GxP Compliance Director to support a critical backfill within a lean, high-impact team in a regulated life sciences environment. This consultant will operate in a leadership capacity, functioning as an embedded team member responsible for driving both strategic GxP compliance initiatives and hands-on validation oversight across IT systems.

This role is highly visible and will play a key part in preparing for an upcoming internal IT audit, while also leading the development and implementation of a GxP compliance framework across IT systems. The ideal candidate brings a strong balance of audit readiness experience, validation leadership, and application-focused GxP expertise.

IT GxP Compliance Director Responsibilities:

GxP Compliance & Audit Readiness

• Serve as the primary point of contact for internal IT audit preparation and execution
• Partner with auditors to facilitate audit activities, provide documentation, and respond to findings
• Ensure systems, processes, and documentation meet GxP regulatory expectations and internal standards
• Lead audit readiness efforts including gap assessments, remediation planning, and inspection support
  
  

Validation Leadership & Oversight

• Provide strategic direction and oversight for IT system validation activities across multiple projects (3 4 concurrent initiatives)
• Manage and mentor two validation consultants, ensuring quality, compliance, and adherence to timelines
• Oversee validation deliverables including validation plans, risk assessments, IQ/OQ/PQ documentation, and summary reports
• Ensure alignment with CSV/CSA best practices and evolving regulatory expectations
  
  

GxP Compliance Framework Development

• Lead the design and implementation of a scalable IT GxP Compliance Framework
• Establish policies, procedures, and governance models to support sustained compliance
• Collaborate with global stakeholders, including parent company (Ono), to align standards and best practices
• Drive continuous improvement initiatives to enhance compliance maturity and operational efficiency
  
  

Cross-Functional Collaboration

• Partner with IT, Quality, Regulatory, and business stakeholders to ensure compliant system implementation and lifecycle management
• Provide guidance on application validation strategy, particularly for Quality and Pharmacovigilance (PV) systems
• Support system lifecycle activities including change control, deviation management, and periodic review
  
  

Required Qualifications:

• Bachelor's degree in Information Technology, Life Sciences, Engineering, or related field
• 10 years of experience in IT validation, CSV/CSA, and GxP compliance within life sciences
• Proven experience in a leadership role directing validation strategy and execution
• Demonstrated experience supporting and interacting with regulatory and/or internal audits
• Strong background in application-focused validation (not lab or manufacturing systems)
  
  

Preferred Qualifications:

• Experience with Quality Systems and Pharmacovigilance (PV) systems
• Familiarity with Veeva Vault (Quality, Safety, or related applications) highly preferred
• Experience working in global environments and collaborating with parent or partner organizations
• Strong knowledge of GAMP 5, FDA, EMA, and other global GxP regulations
  
  

Key Competencies:

• Confident and effective communicator, particularly in audit-facing environments
• Strong leadership and team management capabilities
• Ability to operate both strategically and tactically in a fast-paced environment
• Excellent problem-solving, organizational, and stakeholder management skills
• Ability to quickly integrate into teams and operate with minimal oversight