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Patients and Physicians rely on our diagnostic testing, information, and services to help them make better healthcare decisions. These are often serious decisions with far reaching consequences, and require sensitivity, tact, and a clear dedication to service. It’s about providing clarity and hope.
As a Manager, Quality Assurance - Clinical Trials you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge. You can make a real impact in a market that is growing and developing.
This candidate is eligible for flex-based and remote opportunity out of Marlborough, MA or Seattle, WA or Lewisville, TX.
Manager, Quality Assurance - Clinical Trials – the role:
This is a middle management position in the Quality Assurance career track. Responsible for managing the implementation and maintenance of quality assurance systems and activities in the Specialty Clinical Trials business unit by performing the essential duties and responsibilities of the job. Incumbent works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined procedures and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to company and becomes actively involved as required to resolve problems. Works with minimal supervision
• Demonstrate and apply knowledge of applicable regulations and industry best practices
• Provide guidance and expertise to staff, management and work teams to address quality requirements and improvement
• Provide guidance and expertise on interpretation of, and compliance with, regulatory requirements including CLIA, 21 CFR parts 11 and Good Clinical Practices including ICH E6, 21 CFR parts 50, 54, 56 and 312 at PhenoPath as well as other organizations within Quest as needed.
• Provide guidance and expertise in the preparation of validation deliverables and execution of validation testing. Communicate points effectively through reports and present key findings to a broad audience highlighting CSV issues that need to be addressed. Expected to be the SME (Subject Matter Expert) and provide consultancy to IT and operations on CSV issues.
• Enhance quality in all facets of SCTs offerings and services.
• Ensures clinical trials are audited and inspected at intervals adequate to assure the integrity of the study. Includes performance of periodic process-based inspections, audits of clinical trial data and reports.
• Oversee generation and review of documents used in Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP).
• Oversee audits of study conduct, facilities, and processes.
• Oversee document management (SOP) system for the SCT Business Unit.
• Oversee maintenance of training files for SCT personnel and CVs for external consultants. Oversee maintenance of QA files.
• Administer performance reviews for direct reports in the Quality Assurance department.
Audits and Inspections
• Monitors Clinical studies and assures facility management that studies are in compliance with the applicable regulations.
o Supervises performance of, or performs critical phase inspections of, studies to assure compliance with CAP/CLIA, GCP, GCLP and applicable SOPs; prepares written report of findings.
o Supervises performance of, or performs audits of data and final reports, and provides Quality Assurance Statements, as indicated, for inclusion in Final Reports.
• Reviews clinical and nonclinical documents protocols, study reports, training dossiers, summary documents etc. for compliance with regulations and strategic objectives.
• Performs or coordinates vendor audits of subcontractor laboratories to assure compliance with GCP/GCLPs; provides report of findings to Clinical Laboratory Study Director or Principal Investigator and SCT Management.
• Participates in Lean/Sigma projects and manages teams for various initiatives.
• Reviews / edits existing, and authors new QAU Standard Operating Procedures, as appropriate. Reviews other Standard Operating Procedures and provides editorial comments and comments regarding compliance issues as necessary.
• Provides training and resources to staff relating to quality and regulatory compliance. Provides assistance to management, staff, clients and subcontractors, where necessary, to help them meet their regulatory requirements.
• Applies knowledge of CAP/CLIA, GCP and GCLP on a daily basis, informally and formally. Communicates with staff verbally and in writing regarding regulatory interpretations.
• Assists staff with interpretation of CAP/CLIA, GCP and GCLP.
• Hosts site visitors and auditors from sponsor organizations.
Computerized Systems Validation (CSV)
• Performs and provides support for internal audits of computer systems, validation documentation, IT infrastructure and operations, and computer system vendors
• Advises Operations on system development issues, e.g. validation strategies, preparation and content of validation documentation etc.
• Reviews lifecycle documentation including validation project plans, test scripts, plan deviations etc.
• Reviews change control requests for all validated systems and identify qualification requirements to ensure the validated state is maintained and assist with assessments of the impact of changes on validated systems.
• Verifies that all SCT systems and programs utilized to store and or manipulate clinical trial data are fit for purpose and fully validated prior to use. Conducts audits and prepare reports.
• Performs and provides support for internal audits of equipment qualification documentation including equipment qualification protocols test scripts (IQ, OQ and PQ) and summary reports for equipment qualification.
• Reviews change control requests for all qualified equipment and identify qualification requirements to ensure the qualified state is maintained
• Assist with assessments of the impact of changes on qualified equipment
• May Investigate identified or reported concerns. Documents findings and corrective actions, as applicable
• Maintain and foster an open and communicative work environment.
• Maintains associations with industry colleagues, professional organizations, and regulatory liaisons; keeps abreast of regulatory initiatives and interpretations.
• Upholds and promotes Quest Diagnostics Core Values.
• Other duties may be assigned.
To qualify, the ideal candidate will have the following skills and experience:
• Bachelor's degree in a related scientific or technical discipline
• 5-8 years’ experience in a QA role in a GLP or GCP environment to include internal auditing and Quality Management.
• Demonstrated knowledge of GCP and/or GLP, Standard Operating Procedures, Quality Systems principles and general compliance principles.
• Quality Assurance certification, e.g. RQAP-GCP, CQA preferred
• Knowledge and experience in 21 CFR Part 11
• Familiarity with project management principles
• Experience with, or certification in Lean or Six Sigma
• Travel (10 – 20%): Occasional travel required to other Quest sites or attend conferences.
Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better.
Your Quest career. Seek it out.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity or Citizenship.