Laboratory Quality Assurance Manager, Documentation

Job Description

Job Description

Seeking a Laboratory Quality Assurance Manager, Documentation for a contract testing laboratory serving pharmaceutical and compounding clients. This leader will own QA documentation governance within the Documentation specialty area, including controlled documents and documentation review systems. As part of the broader QA management team, the role also shares responsibility for people leadership, compliance, audit readiness, and continuous improvement.

Essential Duties and Responsibilities:

• Lead assigned QA staff, including workload planning, scheduling, coaching, training, and performance management
• Establish and maintain standards for accurate, complete, contemporaneous, and traceable documentation across QA processes
• Oversee review and approval workflows for SOPs, forms, templates, and controlled documents, ensuring timely completion within established authority
• Ensure quality activities and documentation practices comply with internal procedures, cGMP requirements, regulatory standards, and data integrity expectations
• Identify documentation errors, recurring deficiencies, data integrity risks, and quality trends; coordinate corrective actions and escalate significant concerns to the QA Director
• Monitor and report documentation quality metrics, including review cycle times, recurring errors, and right-first-time performance
• Provide risk-based QA oversight and decision-making for quality records within the assigned area
• Partner with QC, laboratory operations, Sample Management, Client Services, and other QA groups to resolve quality issues and align documentation expectations
• Support internal audits, client audits, regulatory inspections, and ongoing inspection readiness
• Lead improvements to documentation workflows, templates, and electronic systems

Required Qualifications:

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or a related scientific discipline
• 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, data integrity principles, quality systems, and FDA, USP, and ICH expectations
• Demonstrated ability to make sound, risk-based quality decisions
• Strong technical writing and documentation review skills
• Experience supporting client audits and regulatory inspections

Preferred Qualifications:

• Advanced degree in a relevant scientific discipline
• Experience with electronic QMS, LIMS, ELN, or similar systems

\nCompany Description

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.