IT GxP Compliance & CSV Specialist

Default (MSD); Rockville (MD); Hybrid; USD 101,000 - 155,000; Full time

Benefits offered by this job

401(k) plan with company match

Paid vacation and sick leave

Paid holidays

Disability insurance

Parental leave

Fitness club membership contribution

Pet insurance

Job summary

MSD is seeking an Information Technology GxP and Quality Compliance Analyst in Rockville, MD. The role ensures IT systems align with GLP/GCLP requirements and ISO 9001, owning the CSV framework and supporting internal/external audits.

Ideal candidates have a Bachelor’s degree in IT or related field and at least 6 years in GLP/GCLP IT roles, with 3+ years in quality/compliance. Hybrid work and a competitive compensation package are offered.

Qualifications

• This role requires strong GxP compliance knowledge across IT systems.
• Experience validating computerized systems (CSV) and supporting regulatory audits.
• Ability to document processes and maintain ISO 9001 alignment.

Responsibilities

• Ensure IT systems comply with GLP/GCLP and 21 CFR Part 11.
• Own CSV framework, validation plans, and periodic reviews.
• Support audits, sponsor inspections, and CAPA activities.
• Maintain ISO 9001 documentation and KPIs for IT.
• Provide training and guidance on GxP compliance.

Skills

GxP compliance

CSV validation

Regulatory inspections

Quality metrics

Audit readiness

Education

Bachelor’s degree in IT or related field

Equivalent combination of education and experience

Job description

MSD is seeking an Information Technology GxP and Quality Compliance Analyst in Rockville, MD. The role ensures IT systems align with GLP/GCLP requirements and ISO 9001, owning the CSV framework and supporting internal/external audits.

Ideal candidates have a Bachelor’s degree in IT or related field and at least 6 years in GLP/GCLP IT roles, with 3+ years in quality/compliance. Hybrid work and a competitive compensation package are offered.