QC Documentation & Data Integrity Leader

Nova Pneuma; Colorado; On-site; USD 145,000 - 177,000; Full time

Job summary

Nova Pneuma is seeking a (Senior) Manager, QC Documentation Compliance to lead the documentation review process and QC systems management. You will oversee data packages, audits, and GMP compliance across QC documentation, with responsibility for ensuring inspection readiness and adherence to regulatory standards.

The role requires strong organization, attention to detail, and the ability to manage multiple tasks in a matrix environment.

Qualifications

• 5-7 years of data review experience.
• 8+ years of pharmaceutical experience.
• QA experience reviewing documentation preferred.
• Advanced knowledge of GMPs, safety regulations and data integrity.
• Experience with FDA Guidance, ICH Guidelines, and ISO certifications.

Responsibilities

• Manage timely review of QC data processes to ensure data integrity and compliance with SOPs.
• Oversee data reviewers in QC Documentation Compliance group to meet timelines.
• Verify data transfer, calculations, and documented information (e.g., reagent expiry, instrument calibration).
• Compile and file QC data packages and reports in paper and electronic formats.
• Ensure monthly logbook audits are conducted and inspection readiness maintained.

Skills

Well-organized

Multi-tasking

Detail-oriented

Excellent written and oral沟通

Education

BS degree in scientific area or equivalent

Tools

Word

Excel

Job description

Nova Pneuma is seeking a (Senior) Manager, QC Documentation Compliance to lead the documentation review process and QC systems management. You will oversee data packages, audits, and GMP compliance across QC documentation, with responsibility for ensuring inspection readiness and adherence to regulatory standards.

The role requires strong organization, attention to detail, and the ability to manage multiple tasks in a matrix environment.