Manager, CAP CLIA Laboratory Operations

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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 with at least one year experience with high complexity testing, OR

• Associate degree in a laboratory science or medical technology program with at least two years of experience with high complexity testing.

• 10 years of related experience with high complexity testing, CAP/CLIA laboratory operations, and general histology.

• Current Certification by ASCP's Board of Certification as a Histotechnician (HT) or Histotechnologist (HTL) required.

Preferred Qualifications:

• ASCP Board Certification in Immunohistochemistry.

• 5+ years of histology lab experience, including 2+ years in a supervisory or managerial role.

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

• Knowledge of CAP and CLIA regulations for Anatomic Pathology.

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

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

• Excellent written and verbal communication skills.

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.

Benefits

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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