Bioanalytical Quality Assurance Unit Manager

Bioanalytical Quality Assurance Unit Manager

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 is desirable
• Training and experience in a Biosafety Level 2 (BSL-2) laboratory is preferred

Knowledge, Skills and Abilities:

• 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
• 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)

Physical Demands:

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office and laboratory

Work Environment:

This position is primarily performed in a traditional office environment Other assigned responsibilities may be performed in a Biosafety Level 2 laboratory environment up to 20% of the time, interacting with staff who are handling chemical reagents and performing Biosafety Level 2 work.

Compensation

Summary:

The annual base salary for this position ranges from $116,600 to $177,800. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary.

These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

Benefits

Summary:

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our…