CSV Documentation & Data Integrity Lead (Hybrid)

The Fountain Group; Lexington (MA); Hybrid; USD 136,382 - 140,515; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Life insurance

Disability insurance

Hybrid work arrangement

Job summary

The Fountain Group is seeking a qualified candidate in Lexington, MA to act as a subject matter expert across IT systems and data integrity. The role emphasizes compliance, risk assessment, and documentation modernization within QC lab environments.

You will partner with Quality, IT, and business owners to optimize controls, align with 21 CFR Part 11, and drive remediation or optimization plans as needed.

Qualifications

• Bachelor's degree in Science, Engineering, IT, or related field.
• Experience in GxP-regulated pharmaceutical or biotech environments.
• Knowledge of CSV and system lifecycle management.
• Familiarity with data integrity regulations (ALCOA+).
• Ability to facilitate Quality Risk Management activities.

Responsibilities

• Serve as SME across IT systems and data integrity for compliance.
• Modernize system documentation across QC lab systems.
• Perform structured risk assessments using QRM/ICH Q9 principles.
• Advise on audit trails, backup/restore, and user access controls.
• Collaborate with Quality IT and Process Owners to optimize controls.

Skills

Quality Risk Management

Data integrity principles

Regulatory compliance

Cross-functional collaboration

Documentation standardization

Education

Bachelor's degree in Science/Engineering/IT or related field

Tools

CSV

FRS/SDCS

SOPs

SDLC

Job description

The Fountain Group is seeking a qualified candidate in Lexington, MA to act as a subject matter expert across IT systems and data integrity. The role emphasizes compliance, risk assessment, and documentation modernization within QC lab environments.

You will partner with Quality, IT, and business owners to optimize controls, align with 21 CFR Part 11, and drive remediation or optimization plans as needed.