GxP Data Integrity & Quality Systems Consultant

Grove Technical Resources, Inc.; Boston (MA); Hybrid; USD 61,000 - 83,000; Full time

Job summary

A leading consulting firm seeks a GxP Data Integrity & Quality Systems Consultant to oversee GxP computerized systems and compliance activities. Ideal candidates should possess strong expertise in GxP compliance and Data Integrity, alongside a Bachelor's degree in a related field and 10+ years of experience in the pharmaceutical or biotech industries.

Qualifications

• 10+ years in validation or computerized systems within Pharma/Biotech.
• Deep knowledge of global health authority regulations.
• Strong expertise in audit readiness and change control.

Responsibilities

• Lead Data Integrity risk assessments for GxP systems.
• Act as Strategic Quality Lead for computer system lifecycle processes.
• Conduct internal audits on data integrity.

Skills

GxP compliance

CSV

Data Integrity

Project Management

Data Analysis

Education

Bachelor’s degree in Computer Science or Information Systems

Job description

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:

We’re 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:

• Bachelor’s 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

  Medical Practices, Biotechnology Research, and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Grove Technical Resources, INC by 2x

Sign in to set job alerts for “Data Integrity Specialist” roles.

Boston, MA $61,152.00-$82,992.00 1 month ago

Data Engagement Intern, Asian Community Fund

Ethics & Compliance Capabilities Coordinator, Data & Insights

System Safety Analyst - Data and Analytics

Massachusetts, United States $150,000.00-$175,000.00 6 days ago

Boston, MA $55,000.00-$65,000.00 3 days ago

Cambridge, MA $215,000.00-$225,000.00 1 week ago

Marlborough, MA $85,000.00-$110,000.00 1 week ago

Remote Data Migration Analyst - $60-$75k (MS Suite, Excel)

Boston, MA $60,000.00-$75,000.00 2 weeks ago

Boston, MA $80,000.00-$100,000.00 6 days ago

System Safety Analyst - Data and Analytics

Special Agent: Mathametics/Data Expertise

Greater Boston $99,461.00-$128,329.00 3 days ago

Communications Data Analyst - Relocate to Saudi Arabia, Permanent Expat Family Relocation Package

Associate Director, Regulatory Data Governance Lead

Boston, MA $153,600.00-$241,340.00 2 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.