Bioanalytical Quality Assurance Unit Manager

POSITION SUMMARY:

• 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.

DUTIES AND 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

EXPERIENCE AND QUALIFICATIONS:

• 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

• Professional Quality Certification (e.g., ASQ, ASCP) is a plus

• Experience with protein based immunoassays, running antibody-based assays