6284 - IT GxP Compliance Director / SME Consultant

Verista, Inc.•Waltham, MA

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise 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.

Requirements

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)

Nice To Haves

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

Responsibilities

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
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
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
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