Bioanalytical Quality Assurance Unit Manager

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

7d•$116,600 - $177,800•Hybrid

About The Position

The Bioanalytical Quality Assurance Unit (QAU) Manager is responsible for implementing and maintaining QAU laboratory policies and procedures to ensure that the Bioanalytical Laboratory’s (BAL) services comply with applicable elements of Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP). Additionally, this position manages QAU staff, conducts GLP phase audits, acts as subject matter expert (SME) for customer questionnaires and audits, and reviews all Bioanalytical Laboratory Corrective and Preventive Action (CAPA) documentation and associated activities in support of clinical/preclinical study sample analysis and assay validations.

Requirements

Bachelor’s degree in health or science related field is required
A minimum of 7 years of experience in a Quality role in support of GLP/GCLP bioanalysis required
A minimum of 2 years of supervisory/mentoring/management experience is required
Strong scientific fundamentals and analytical background
Intermediate level understanding of scientific text and data
Advanced level knowledge of FDA GLP requirements and applicability of EU M6 GCP requirements to bioanalytical testing laboratories
Awareness of FDA Bioanalytical Method Validation Guidance, International Council for Harmonisation (ICH) M10 bioanalytical method guidance and Organisation for Economic Co-operation and Development (OECD) GLP guidance series
Demonstrated ability to identify and implement process improvements
Effective leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results
Excellent interpersonal skills and ability to work well with employees at all levels
Effectively communicate issues/problems and results that impact timelines, accuracy and compliance of laboratory data and associated documentation
Effectively communicate performance goals and expectations
Strong organizational and project management skills with the ability to organize multiple tasks and set priorities under deadlines with minimal supervision
Proficiency in MS Office suite; familiar with electronic file management using SharePoint (end user minimum)

Nice To Haves

Professional Quality Certification (e.g., ASQ, ASCP) is a plus
Experience with protein based immunoassays, running antibody-based assays is desirable
Training and experience in a Biosafety Level 2 (BSL-2) laboratory is preferred

Responsibilities

Implement and maintain QAU laboratory policies and procedures in compliance with applicable elements of GLP and GCLP
Supervise QAU staff responsible for technical reviews of study reports and study files, archiving, and execution of internal audits of the bioanalytical laboratory
Function as SME for services-related customer questionnaires and audits
Coordinate BAL resources to ensure timely completion of questionnaires
Assist QA management with scheduling of BAL customer audits, preparation of documents required for audit execution, responding to audit findings, and coordinating completion of associated CAPA activities
Review deviations and CAPA’s generated by BAL staff, assist with root cause investigations and associated documentation, assist with customer communications/meetings related to deviations and CAPAs
Oversee implementation of continuous improvement initiatives identified by QAU staff or as a result of internal or external audits
Train and mentor BAL staff in GLP/GCLP principles, root cause investigations, CAPA documentation best practices
Establish and monitor staff performance and development goals, assign accountabilities, set objectives, establish priorities, and provide continuous feedback and recognition on performance.
Promote a culture of high performance and continuous improvement that values learning and a commitment to quality