Principal Specialist - Quality Validation

About the role

For our client, we are seeking a Principal Specialist - Quality Validation to join the team of a leader in the Pharmaceuticals & Biotech space. This remote role will lead enterprise software validation activities across a global, regulated environment. The position is a key partner to quality, IT, manufacturing, and compliance stakeholders, helping ensure systems and processes remain aligned with cGMP and data integrity expectations. You will also provide strategic input on validation matters that support operational excellence and regulatory readiness.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Oversee global enterprise software validation efforts
• Review and approve validation lifecycle deliverables
• Approve enterprise software change controls, CAPAs, and deviations
• Support global data integrity initiatives
• Ensure compliance with cGMPs and regulatory requirements

Qualifications

• BS with 8+ years of experience or MS with 6+ years of experience in a QA or GMP environment
• Expert knowledge of 21 CFR Part 11 and/or EU Annex 11
• Strong background in data integrity and computer system validation
• Experience in IT quality within FDA-regulated manufacturing
• Proficiency in analyzing and interpreting complex regulations and technical documents

Benefits

• International and domestic travel opportunities, approximately 10%
• Exposure to cutting-edge validation processes in a CDMO setting
• Strategic input in global software validation matters
• Opportunity to work within an FDA-regulated environment
• Potential to influence quality assurance practices across the organization

Pay

Compensation: $110,000 – $130,000 annually