Manager, CAP CLIA Laboratory Operations

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The Position

Manager, CAP CLIA Laboratory Operations - Tucson, AZ

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Opportunity:

Responsible for the day-to-day supervision and oversight of the high-complexity testing laboratory operation and personnel. The duties involve training and assessing the competencies of personnel, validating new assays, instruments and technology and creating and revising operating procedures. Works closely with the CAP/CLIA laboratory medical director, CDx Biosample Management (BSM), in-house pathologists, clinical sciences management (CSM), Assay Development team, Companion Diagnostics team, and other divisions of Ventana/Roche.in ensuring quality control and quality assurance and compliance with CAP, CLIA, state and federal regulations; Assists in creating department budget, managing finances, and interacting with clients.

Key Roles & Responsibilities:

• Manages a clinical trial testing laboratory specializing in IHC and ISH tissue staining, ensuring high-quality and timely patient results for pharmaceutical clients.

• Oversees assay validation prior to implementation, and continuously monitors quality control and quality assurance in compliance with regulatory standards.

• Shares responsibility with the Senior Supervisor of CDx Biosample Management for sample accessioning, handling protocols, and inventory management.

• Supervises and supports laboratory staff through performance reviews, real-time feedback, corrective actions, and ongoing professional development. Ensures all certifications and competencies remain current.

• Leads laboratory participation in proficiency testing programs to maintain the accuracy and reliability of patient testing results.

• Troubleshoots technical issues related to tissue staining, instrumentation, and reagent performance; ensures regular maintenance and qualification of lab equipment and facilities.

• Serves on the safety committee to maintain compliance with CAP, CLIA, Roche, and other regulatory standards.

• Represents the laboratory during internal and external audits and inspections, including those conducted by CAP, CLIA, FDA, and clients.

• Supports the CAP Laboratory Medical Director in assessing lab capacity and workflow, presenting operational needs to senior leadership, and responding to client inquiries. Also participates in scientific symposia and cross-functional Roche projects to stay current with evolving technologies and regulatory requirements.

Who You Are:

• Bachelor's degree in a chemical, physical, biological or clinical laboratory science or medical technology

• 5+ years of related experience with high complexity testing, CAP/CLIA laboratory operations, and general histology, including 2+ years in a supervisory or managerial role.

• Knowledge of CAP and CLIA regulations for Anatomic Pathology.

• Excellent written and verbal communication skills. 

• Strong team management skills; experienced in cross-functional collaboration.

Preferred Qualifications:

• ASCP Board Certification in Immunohistochemistry.

• Background in clinical anatomic pathology; familiarity with digital and molecular pathology is a plus.

• Proficient in clinical histological techniques, including validation and troubleshooting.
   

Relocation benefits are available for this job posting

The expected salary range for this position based on the primary location of Tucson, AZ is between $109,800 and $203,800.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.