Senior QA Specialist, Facilities & Compliance (Biopharma)

Location: USA - NC - Durham - National Way

Company

hirify.global supports clinical and commercial biopharmaceutical manufacturing operations.

What you will do

• Provide Quality Assurance oversight for GMP facilities, utilities, equipment, Engineering, Validation, Cleaning Validation, Metrology, and computerized systems.
• Review and approve qualification and validation protocols and reports, risk assessments, deviations, CAPAs, change controls, and return-to-service documentation.
• Oversee commissioning, qualification, validation, cleaning validation, and computerized system validation activities throughout their lifecycle.
• Assess qualification and validation impacts related to new products, technology transfers, facility and process changes, and client onboarding.
• Support facility upgrades, capital projects, shutdowns, equipment modifications, manufacturing readiness, audits, and regulatory inspections.
• Identify and escalate compliance risks while driving quality improvements with cross-functional teams.

Requirements

• Bachelor’s degree with 8+ years of relevant experience, or Master’s degree with 5+ years of relevant experience, in a QA role within a cGMP-regulated biopharmaceutical or equivalent environment.
• Experience reviewing and approving change controls, deviations, investigations, and CAPAs.
• Knowledge of U.S. and EU cGMP regulations and guidelines.
• Strong technical judgment, problem-solving, communication, technical writing, and cross-functional collaboration skills.
• Ability to independently manage multiple priorities and provide pragmatic, risk-based Quality guidance in a fast-paced manufacturing environment.

Nice to have

• Experience supporting clinical and/or commercial biopharmaceutical manufacturing.
• Experience with cleaning validation protocols, risk assessments, sampling strategies, deviations, and lifecycle activities.
• Experience providing QA oversight for GMP facility, utility, equipment, and computerized system qualification and validation.

Culture & Benefits

• Full-time employment.
• Cross-functional collaboration with Engineering, Facilities, Validation, Manufacturing, MSAT, IT, and other teams.
• Work supporting clinical and commercial manufacturing quality and compliance.