VHCS
The Molecular & Validation Manager is responsible for overseeing the daily operations of the Molecular Department, ensuring high-quality molecular diagnostic testing and regulatory compliance. This role provides leadership in validation studies, quality assurance (QA), and quality control (QC), while optimizing laboratory workflows and personnel management. The Molecular & Validation Manager works closely with senior leadership to drive operational efficiency, maintain regulatory adherence, and promote continuous improvement in molecular diagnostics.
Working Relationships1. Reports To: Vice President of Technical Support2. Directly Supervises: Molecular Laboratory Staff3. Indirectly Supervises: Not Applicable4. Type of Supervision Received: General Direction5. Internal Relationships: Extensive6. External Relationships: Moderate
Essential Duties & Responsibilities
Oversee daily molecular laboratory operations, including workflow optimization and resource management. Ensure timely and accurate molecular diagnostic testing in compliance with CAP, CLIA, and state regulations. Develop and implement operational strategies to improve efficiency and reduce turnaround time. Supervise and support laboratory staff, fostering a collaborative and high-performance work environment. Manage inventory, supplies, and vendor relationships to ensure uninterrupted laboratory function. Performs tasks of Molecular Technologist in his/her absence. Lead validation studies for new molecular assays, instruments, and workflows. Prepare and submit comprehensive validation reports for regulatory review and approval. Ensure adherence to CAP, CLIA, and state regulatory requirements for all molecular testing procedures. Maintain thorough validation documentation and update standard operating procedures (SOPs) as required. Participate in regulatory inspections and audits, ensuring laboratory readiness and compliance. Quality Assurance & Quality Control
Oversee QA/QC programs, including proficiency testing, internal audits, and compliance monitoring. Implement and maintain robust quality control measures to ensure result accuracy and reliability. Identify and resolve non-conformances, deviations, and compliance risks. Regularly review and revise SOPs to align with best practices and evolving regulatory standards. Personnel Training & Development
Train and mentor laboratory personnel on validation procedures, QA/QC protocols, and regulatory requirements. Conduct competency assessments and develop training materials to ensure staff proficiency. Foster a culture of continuous learning, professional development, and teamwork within the department. Provide performance feedback and participate in personnel evaluations. Professional Requirements
Adheres to dress code, maintaining a neat and professional appearance. Completes annual educational and continuing education requirements. Ensures patient confidentiality at all times. Maintains current knowledge of laboratory policies and regulatory requirements. Reports on time and completes tasks within designated deadlines. Represents the organization in a positive and professional manner. Actively participates in departmental meetings and performance improvement initiatives. Complies with all organizational policies and ethical business practices. Education, Experience, and Skills Required
Bachelor's degree in Molecular Biology, Clinical Laboratory Science, or a related field (Master's preferred). Minimum of 10+ years of experience in molecular diagnostics, including laboratory management and validation. Strong knowledge of CAP, CLIA, and state regulatory requirements. Proven experience in validation studies, data analysis, and regulatory reporting. Excellent problem-solving, organizational, and leadership skills. Strong technical writing skills for preparing validation and regulatory reports. Ability to work in a high-complexity laboratory environment with a focus on continuous improvement. ASCP certified Technologist in Molecular Biology Strong background in Cancer Genomics
Working Relationships1. Reports To: Vice President of Technical Support2. Directly Supervises: Molecular Laboratory Staff3. Indirectly Supervises: Not Applicable4. Type of Supervision Received: General Direction5. Internal Relationships: Extensive6. External Relationships: Moderate
Essential Duties & Responsibilities
Oversee daily molecular laboratory operations, including workflow optimization and resource management. Ensure timely and accurate molecular diagnostic testing in compliance with CAP, CLIA, and state regulations. Develop and implement operational strategies to improve efficiency and reduce turnaround time. Supervise and support laboratory staff, fostering a collaborative and high-performance work environment. Manage inventory, supplies, and vendor relationships to ensure uninterrupted laboratory function. Performs tasks of Molecular Technologist in his/her absence. Lead validation studies for new molecular assays, instruments, and workflows. Prepare and submit comprehensive validation reports for regulatory review and approval. Ensure adherence to CAP, CLIA, and state regulatory requirements for all molecular testing procedures. Maintain thorough validation documentation and update standard operating procedures (SOPs) as required. Participate in regulatory inspections and audits, ensuring laboratory readiness and compliance. Quality Assurance & Quality Control
Oversee QA/QC programs, including proficiency testing, internal audits, and compliance monitoring. Implement and maintain robust quality control measures to ensure result accuracy and reliability. Identify and resolve non-conformances, deviations, and compliance risks. Regularly review and revise SOPs to align with best practices and evolving regulatory standards. Personnel Training & Development
Train and mentor laboratory personnel on validation procedures, QA/QC protocols, and regulatory requirements. Conduct competency assessments and develop training materials to ensure staff proficiency. Foster a culture of continuous learning, professional development, and teamwork within the department. Provide performance feedback and participate in personnel evaluations. Professional Requirements
Adheres to dress code, maintaining a neat and professional appearance. Completes annual educational and continuing education requirements. Ensures patient confidentiality at all times. Maintains current knowledge of laboratory policies and regulatory requirements. Reports on time and completes tasks within designated deadlines. Represents the organization in a positive and professional manner. Actively participates in departmental meetings and performance improvement initiatives. Complies with all organizational policies and ethical business practices. Education, Experience, and Skills Required
Bachelor's degree in Molecular Biology, Clinical Laboratory Science, or a related field (Master's preferred). Minimum of 10+ years of experience in molecular diagnostics, including laboratory management and validation. Strong knowledge of CAP, CLIA, and state regulatory requirements. Proven experience in validation studies, data analysis, and regulatory reporting. Excellent problem-solving, organizational, and leadership skills. Strong technical writing skills for preparing validation and regulatory reports. Ability to work in a high-complexity laboratory environment with a focus on continuous improvement. ASCP certified Technologist in Molecular Biology Strong background in Cancer Genomics