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6284 - IT GxP Compliance Director / SME Consultant

Waltham, MA

Description

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.

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

 

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$107,800 - $175,000 USD

Benefits

Why Choose Verista?

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

For more information about our company, please visit us at Verista.com

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