(Senior) Manager, QC Documentation Compliance

About the Role

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

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 in their daily assignments to ensure review of relevant QC data and corresponding documentation is completed within expected timelines.
• Manage the verification of 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 related to both internal and external audits.
• Conduct periodic informal laboratory audits to ensure inspection readiness of the labs.
• Participate in addressing internal and external audit findings within a defined timeframe.
• Manage the inspection readiness program with guidance from the QC leadership team.
• Verify that all analyses performed are as per the test method and/or compendial methods, and are compliant with GMP requirements.
• Manage compendial monitoring and regulatory surveillance program for updates relevant to QC and propose appropriate action.
• Ensure lab investigation related to QC testing, root cause analysis, and deviation reporting are compliant and completed within the required timeframe.
• 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, specifications, etc.
• 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 on a daily basis.

Requirements

• Well-organized, capable of multitasking, and able to collaborate with individuals in a matrix environment.
• Able to maintain detailed and accurate records.
• Excellent communication, written, and oral 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.
• 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 is a plus.
• Prior managerial or lead experience required.

Skills

• QC documentation compliance
• QC data review
• Data integrity
• GMP, GDP, GLP
• Quality systems
• Inspection readiness
• Internal and external audits
• Laboratory audits
• Analytical and compendial methods
• QC instrumentation
• Equipment qualification
• Software validation
• Regulatory surveillance
• FDA guidance, ICH guidelines, ISO standards
• SOP and document lifecycle management
• Laboratory investigations
• Root cause analysis
• Deviations, NCRs, change control, CAPA
• QA documentation review
• Records management
• Microsoft Word, Microsoft Excel
• Team leadership
• Project management
• Cross-functional collaboration
• Communication
• Attention to detail
• Pharmaceutical industry experience

Pay

$70 - $91 per hour

Schedule

Onsite, W2 Contract

Location: Fremont, CA