Senior Data Integrity Consultant
Location: San Diego, California
Country: United States
Category: Engineering
Workplace Location: Onsite
Employment Type: Contract
Posted Date: May 7, 2026
Job ID: 647259
Job Description
Job Title: Senior Data Integrity Consultant
Location: San Diego, CA
Contract Length: 7 Months
Pay Range: $80/hr - $85/hr (DOE)
The Planet Group is seeking an experienced Senior Data Integrity Consultant (GxP) to support a clinical-stage biopharmaceutical site in San Diego. This on-site consulting role is responsible for leading and governing the site's Data Integrity (DI) program and providing Quality Assurance oversight for computerized systems and associated paper-based systems.
Reporting directly to the Site Quality Head, this role serves as the primary Quality voice for Data Integrity and ensures compliance with global regulatory expectations. The consultant will provide independent Quality oversight across laboratory, manufacturing, and quality environments, ensuring that all data is attributable, accurate, secure, and compliant with applicable GxP regulations
Qualifications:
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field, (Equivalent education and experience may be considered)
- Minimum 8+ years of experience in a GxP-regulated environment.
- Experience in pharmaceutical, biotech, or cell and gene therapy manufacturing preferred
- Demonstrated experience in Data Integrity, Computer System Validation, and Quality Compliance
- Expert knowledge of:
- FDA 21 CFR Part 11, 210/211, and 820
- EU EudraLex Volume 4 (Annex 11 and Chapter 4)
- GAMP 5 and risk-based validation approaches
- ALCOA+ principles and data governance frameworks
- Strong knowledge of Quality Management Systems in a GxP environment
- Experience with Change Control, Deviations, CAPA, Document Control, and Training systems
- Hands-on experience with EDMS, LMS, and laboratory or manufacturing systems
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Strong written and verbal communication skills
- Ability to author and review SOPs, work instructions, and validation documentation
- Strong attention to detail with the ability to manage multiple priorities
- Ability to work independently and collaboratively in a fast-paced environment
- Experience developing and delivering training on DI and CSV topics
- Ability to lift up to 20 pounds as required
Responsibilities:
- Data Integrity Program Leadership
- Lead the deployment, enhancement, and implementation of the site Data Integrity program
- Conduct data integrity gap assessments, identify risks, and develop mitigation plans
- Ensure compliance with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, and EudraLex Volume 4
- Provide Quality oversight for audit trail practices, data governance, and data lifecycle controls
- Ensure data quality, backup, recovery, and system security controls are effective
- Act as the primary QA authority for Data Integrity standards and practices
- Ensure ALCOA+ principles are incorporated into system architecture and procedures
- Review and approve SDLC deliverables including URS, design specifications, and test plans
- Oversee implementation of engineering controls such as access restrictions and audit trails
- Validation & Computer Systems Assurance
- Author, review, and approve validation documentation including:
- Validation Plans
- Periodic System Reviews (PSR)
- Validation Summary Reports
- IQ/OQ/PQ test scripts
- User Requirements Specifications (URS)
- Risk Assessments
- Support system requalification and ongoing maintenance of validated state
- Serve as the Quality Lead on system implementation and improvement projects
- Oversee system lifecycle activities to ensure sustained compliance
- Support assessment and remediation of legacy systems
- Author, review, and approve validation documentation including:
- Operational Compliance & Audit Readiness
- Lead and execute Periodic System Reviews (PSR)
- Perform User Account Reviews (UAR) to ensure appropriate GxP access controls
- Provide Quality oversight for change control activities
- Lead or support internal audits and regulatory inspections (FDA, EMA)
- Support investigation and execution of corrective action plans
- Apply risk management principles to identify and escalate compliance risks
- Prepare management-level compliance and validation status reports
- Continuous Improvement & Collaboration
- Enhance Quality procedures related to Data Integrity and computer systems compliance
- Align site-level practices with global quality standards
- Act as a Quality consultant to technical and functional SMEs
- Collaborate cross-functionally in support of site and company goals
EEO Statement
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process, and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com or @launchcg.com) - and not a domain with an alternative extension like .net, .org, or .jobs.
The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity, and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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About The Planet Group
The Planet Group is a global professional services firm delivering strategic staffing and advisory solutions. We operate at the intersection of talent and transformation – connecting the right people with the right opportunities in the areas of technology, engineering, accounting & finance, digital marketing, and manufacturing.
As one of the largest staffing companies in the US, we operate with a global reach and a performance-first mindset. We partner with clients to move fast, stay agile, and drive measurable results – building high-impact teams that fuel transformation and growth.
