(Senior) Manager, QC Documentation Compliance

About the role

This position has direct responsibility and accountability for all phases of the documentation and data review process, including QC systems such as inspection/audit management, equipment qualification/software validation, compendial monitoring/regulatory surveillance, document lifecycle management, and quality systems management. The role requires operational thinking to keep projects on schedule.

Responsibilities

• Manage the timely review of QC data processes to ensure data integrity and compliance with company SOPs and specifications, and audit data packages for both scientific merit and GDP.
• Manage the data reviewers in the QC Documentation Compliance group to ensure review of relevant QC data and documentation is completed within expected timelines.
• Verify data transfer, calculations, and documented information such as reagent expiry, instrument calibration, logbook entries, standards, and controls.
• Compile and file QC data packages and reports in both paper and electronic formats.
• Ensure monthly logbook audits are successfully conducted.
• Manage compliance-related activities for both internal and external audits.
• Conduct periodic informal laboratory audits to ensure inspection readiness.
• Participate in addressing internal and external audit findings within defined timeframes.
• Manage the inspection readiness program with guidance from the QC leadership team.
• Verify that all analysis is performed as per test method and/or compendial methods and compliant with GMP requirements.
• Manage the compendial monitoring and regulatory surveillance program for updates relevant to QC and propose appropriate actions.
• Ensure lab investigations related to QC testing, root cause analysis, and deviation reporting are compliant and completed within required timeframes.
• Generate new and/or revise existing department-related SOPs. Track periodic assessment of SOPs to ensure revisions occur on time and represent current compliant procedures.
• Oversee QC document lifecycle management of QC SOPs, work instructions, test methods, and specifications.
• Complete training for QC systems SOPs in a timely manner.
• Oversee QC quality systems management of LIRs, deviations/NCRs, change controls, CAPAs, etc.
• Utilize knowledge of good documentation practices and good laboratory practices daily.
• Perform other duties as assigned.

Requirements

• BS degree in a scientific area or equivalent.
• 5-7 years of data review experience.
• 8+ years of pharmaceutical experience.
• Knowledgeable in FDA Guidance, ICH Guidelines, and ISO certifications.
• QA experience reviewing documentation preferred.
• Advanced knowledge of analytical methods and testing using QC-related instrumentation.
• Advanced knowledge of GMPs, safety regulations, and data integrity.
• Experience in Health Authority inspections a plus.
• Prior managerial or lead experience preferred.

Skills

• Well-organized, capable of multi-tasking, and able to collaborate in a matrix environment.
• Able to maintain detailed and accurate records.
• Excellent written and oral communication skills.
• Motivated and flexible to work in a dynamic group.
• Must work with a balance of both speed and accuracy.
• Capable of working independently.
• Ability to remember and accurately follow detailed instructions.
• Experience with computer software such as Word, Excel, etc.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Potentially prolonged periods standing.
• Must be able to lift up to 15 pounds at times.
• Must be willing to travel.

Pay

The base salary for this role starts at $161,000. Individual pay may vary based on additional factors, including job-related skills, experience, and relevant education or training. The compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions.