Principal Specialist - Quality Validation (IT Validation)

Location: Remote in the USA, North Carolina; approximately 10% domestic and international travel required.

Company

hirify.global is a contract development and manufacturing organization providing biopharmaceutical development and manufacturing services.

What you will do

• Provide global quality oversight of enterprise software validation in a CDMO environment.
• Review and approve validation lifecycle deliverables for enterprise software projects.
• Review and approve software-related change controls, CAPAs, and deviations.
• Provide strategic and technical expertise on global software validation matters.
• Support global data integrity initiatives and ensure compliance with cGMP, legal, regulatory, and internal requirements.

Requirements

• BS degree with 8+ years of experience, or MS degree with 6+ years of experience, in a QA or GMP environment, or equivalent experience.
• Experience with data integrity, computer system validation, and IT quality in an FDA-regulated manufacturing environment.
• Expert knowledge of 21 CFR Part 11 and/or EU Annex 11.
• Ability to analyze and author complex technical and regulatory documentation.
• Ability to solve practical problems in situations with limited standardization and communicate effectively with colleagues, managers, clients, and other stakeholders.

Culture & Benefits

• Remote work arrangement in the USA.
• Approximately 10% domestic and international travel.
• Equal opportunity and affirmative action employer committed to workforce diversity.