Quality Assurance Manager, Documentation

Job Description

Job Description

The Quality Assurance Manager, Documentation provides leadership and quality oversight within the Documentation specialty area, owning QA documentation governance, controlled documentation, and documentation review systems.

This role shares responsibility, alongside all QA Managers, for people leadership, compliance, audit readiness, cross-functional partnership, quality decision-making, and continuous improvement.

Primary Responsibilities

• Lead assigned QA personnel, including workload planning, scheduling, coaching, performance management, training, and development
• Ensure quality activities comply with internal procedures, cGMP requirements, applicable regulatory standards, and data integrity expectations
• Provide QA oversight and risk-based decision-making within your assigned area, including review and approval of quality records, procedures, and documentation within established authority
• Identify quality risks, recurring issues, and performance trends, escalating significant concerns to the QA Director
• Partner with QC, laboratory operations, Sample Management, Client Services, and other departments to resolve quality issues and support business priorities
• Support internal audits, client audits, regulatory inspections, and ongoing inspection readiness
• Drive continuous improvement, right-first-time performance, and consistent application of quality standards
• Maintain documentation, metrics, and reporting for the assigned QA function

Documentation Responsibilities

• Establish and maintain standards for accurate, complete, contemporaneous, traceable, and compliant documentation across assigned QA processes
• Oversee documentation review workflows, including SOPs, forms, templates, and controlled documents, ensuring timely completion of assigned records
• Identify documentation errors, recurring deficiencies, and data integrity risks, and coordinate corrective actions
• Monitor documentation quality metrics, including review cycle times, recurring errors, and right-first-time performance
• Ensure documentation practices support cGMP compliance, data integrity, audit readiness, and regulatory defensibility
• Partner with other QA pillars to align documentation expectations across Microbiology, Investigations, and BRT
• Lead improvements to documentation workflows, templates, and electronic systems

Desired Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred where relevant
• Extensive QA/QC experience in a regulated pharmaceutical, compounding, or laboratory environment
• Direct people leadership experience, including workload management, coaching, performance management, and staff development
• Strong working knowledge of cGMP requirements, data integrity principles, quality systems, and applicable FDA, USP, and ICH expectations
• Demonstrated ability to make sound, risk-based decisions and manage competing priorities in a fast-paced environment
• Strong technical writing, documentation review, and cross-functional communication skills
• Experience supporting client audits and regulatory inspections
• Experience with electronic QMS, LIMS, ELN, or similar systems preferred

Real People. Real Connections. Real Results.

That's the Messina Talent Advantage.

For more than 40 years, Messina's Talent practice has continuously evolved to meet the needs of our clients. We not only help our clients fill roles and build their teams, but we also help them better understand their workforce and develop strategic talent initiatives that drive value for their organizations.

Messina Talent Advisors, a Messina Group Company, has the network, proven processes, and all the latest technologies to connect the right candidates with the right jobs - faster.

Company Description

Real People. Real Connections. Real Results.\r\n\r\nThat's the Messina Talent Advantage.\r\n\r\nFor more than 40 years, Messina's Talent practice has continuously evolved to meet the needs of our clients. We not only help our clients fill roles and build their teams, but we also help them better understand their workforce and develop strategic talent initiatives that drive value for their organizations.\r\n\r\nMessina Talent Advisors, a Messina Group Company, has the network, proven processes, and all the latest technologies to connect the right candidates with the right jobs - faster.