Senior CSV Analyst — IT Compliance & Validation

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Leading pay and annual performance bonus

Generous paid time off, including 14 paid holidays

Health Insurance, Dental Insurance, Vision Insurance

Guaranteed 8% 401(k) contribution

Family-focused benefits including paid parental leave

Tuition assistance

Life & Disability Insurance

Job summary

Initial Therapeutics, Inc. in Clayton, NC is seeking an experienced professional in IT Compliance. The position requires expertise in Computer Systems Validation and process improvement to ensure compliance and support product quality.

Ideal candidates have at least seven years in IT compliance, preferably in the pharmaceutical industry, along with a Bachelor's degree in a relevant field. The role offers competitive pay, health benefits, and opportunities for professional development.

Qualifications

• Minimum of seven years of experience in IT compliance in the pharmaceutical industry.
• Minimum of five years of experience in validation and testing of IT solutions.
• Certified Software Quality Engineer (CSQE) is preferred.

Responsibilities

• Ensure IT solutions comply with regulations and standards.
• Conduct risk assessments and impact analyses.
• Provide leadership and expertise in IT CSV.

Skills

Problem-solving

Excellent communication skills

IT compliance

Collaboration

Planning

Education

Bachelor’s Degree in IT, Engineering, Science, or relevant field

Master’s degree in IT, Engineering, Science, or relevant field

Tools

HP ALM

MS Office

Job description

Initial Therapeutics, Inc. in Clayton, NC is seeking an experienced professional in IT Compliance. The position requires expertise in Computer Systems Validation and process improvement to ensure compliance and support product quality.

Ideal candidates have at least seven years in IT compliance, preferably in the pharmaceutical industry, along with a Bachelor's degree in a relevant field. The role offers competitive pay, health benefits, and opportunities for professional development.