GxP Data Integrity & Quality Systems Consultant

GxP Data Integrity & Quality Systems Consultant

GxP Data Integrity & Quality Systems Consultant

1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Grove Technical Resources, INC Senior Recruiting Manager @ Grove Technical Resources, INC | Team Leadership, Recruitment

Job Title: GxP Compliance & Data Integrity Consultant Location: Boston, MA (Hybrid 3 days onsite weekly) Duration: 24 Months Note: Parking is not provided Job Summary: Were seeking a seasoned Quality Systems & Data Integrity Lead to oversee GxP computerized systems, data integrity, and compliance activities across global pharma/biotech programs. This role acts as a strategic quality partner and subject matter expert in electronic data integrity and system lifecycle activities. Key Responsibilities: Lead Data Integrity risk assessments and remediation plans for GxP systems. Act as Strategic Quality Lead for computer system lifecycle (CSV/SLC) processes. Perform end-to-end process mapping, gap analysis, and data flow evaluations. Collaborate with QA teams on SOP/work instruction creation and review. Conduct internal audits on data integrity; lead governance of GxP systems. Provide input on industry trends to guide continuous improvement and training gaps. Required Skills: Strong expertise in GxP compliance, CSV, and 21 CFR Part 11 regulations. Hands-on experience in electronic data integrity, quality systems, and audit readiness. Proven ability to communicate complex regulatory topics effectively. Strong project management, problem-solving, and data analysis skills. Experience with risk management and change control processes. Qualifications: Bachelors degree in Computer Science, STEM, or Information Systems. 10+ years in validation or computerized systems within Pharma/Biotech. Deep knowledge of global health authority regulations and industry best practices. Preferred: Certified Quality Auditor (ASQ) or Certified Data Integrity Manager. Willingness to travel up to 25%. Seniority level

Seniority level

Mid-Senior level Employment type

Employment type

Contract Job function

Job function

Product Management, Engineering, and Management Industries

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