Global IT Validation Lead (cGMP)

KBI Biopharma, Inc.; North Carolina; Hybrid; USD 118,000 - 162,800; Full time

Benefits offered by this job

Annual bonus structure

Medical, dental, and vision coverage

Paid PTO and holidays

Sabbatical program

401(k) matching with 100% vesting in 60 days

Employee recognition programs

Job summary

KBI Biopharma, Inc. is looking for a Principal or Senior Validation Specialist in Durham, NC. This role involves providing strategic oversight of global software validation to ensure compliance with cGMP and regulatory requirements. The ideal candidates will have extensive experience in computer systems validation and a thorough understanding of data integrity.

The position offers a competitive salary range and comprehensive benefits including medical coverage, a 401(k) matching program, and paid PTO.

Qualifications

• 15+ years of experience in a cGMP environment for Principal role.
• 8+ years of experience in a cGMP environment for Senior role.
• Expert knowledge of 21CFR Part 11 and EU Annex 11.

Responsibilities

• Oversee enterprise software validation globally.
• Provide validation direction for validation lifecycle deliverables.
• Review and approve enterprise software change controls.

Skills

cGMP experience

Data Integrity

Computer Systems Validation

Regulatory Compliance

Education

BS/MS in relevant field

Job description

KBI Biopharma, Inc. is looking for a Principal or Senior Validation Specialist in Durham, NC. This role involves providing strategic oversight of global software validation to ensure compliance with cGMP and regulatory requirements. The ideal candidates will have extensive experience in computer systems validation and a thorough understanding of data integrity.

The position offers a competitive salary range and comprehensive benefits including medical coverage, a 401(k) matching program, and paid PTO.