Manager, Quality Operations

The Manager, Quality Operations is responsible for ensuring the quality, timeliness, and regulatory compliance of operations within a central laboratory supporting clinical trials. This role oversees the implementation and maintenance of the Quality Management System (QMS), manages the Quality Event and CAPA program, ensures adherence to GCP and applicable regulatory standards, and facilitates the audit program. The manager guides and supports business groups, subject matter experts (SMEs), vendors, and management in issue management, impact assessment, root cause analysis, corrective and preventive action (CAPA), effectiveness checks, and training. The manager plays a key role in driving continuous improvement and maintaining high standards of data integrity and clinical quality performance.
This is a fully remote role.
Essential Duties and Responsibilities

Champion Quality initiatives, ensuring alignment with global regulatory standards and corporate excellence (e.g., CLIA, CAP, GCP, ICH, FDA, EMA).
Assess and report on compliance with clinical trial protocols, sponsor requirements, and regulatory guidelines.
Manage and oversee Quality Events from issue identification through investigation, containment, root cause analysis, correction, implementation of robust CAPA plans, and effectiveness monitoring.
Partners with internal Quality Event action owners to manage all aspects of Quality Event activities, including gaining the commitment of cross-functional resources, scheduling Quality Event team meetings, and ensuring deliverables are met per project timelines.
Perform timely, detailed Quality Event tasks, including assessing issue descriptions, reviewing Quality Event data sources, defining issues and impact assessments, and assisting with root cause analysis and quality problem solving.
Ensure Quality Event and CAPA action plans are robust and executed promptly, with the appropriate sense of urgency.
Work effectively with all levels of management to ensure Quality Event action plans can be supported and that the costs and resources needed to implement the plans are available.
Train and mentor Quality Event owners in all required elements and best practices of Quality Event management, including containment, root cause analysis, correction, corrective and preventive actions, and effectiveness checks.
Support vendor management activities related to quality issues, including issue resolution, CAPA follow-up, and effectiveness checks.
Prepare for and facilitate sponsor audits, regulatory inspections (e.g., CLIA, CAP, FDA, EMA), and internal audits, and represent Quality Events during audits and Quality Event Review Board meetings.
Coordinate timely and strategic resolution of audit findings and CAPAs, reinforcing a culture of accountability and continuous improvement.
Collaborate with lab operations, data management, project teams, and others to ensure quality in sample handling, testing, and reporting.
Review method validations, equipment qualifications, and laboratory investigations.
Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
Perform periodic trend analysis and CAPA effectiveness measures for all quality system events and identify opportunities for improvement.
Identify process inefficiencies and facilitate quality improvement initiatives across departments.
Monitor and report quality KPIs (e.g., audit outcomes, deviation trends, CAPA effectiveness).
Provide regular updates to leadership and contribute to strategic quality planning.
Prepare training materials and conduct training for QMS topics.
Collaborate with Human Resources regarding training program requirements affected by the QMS.
Perform other tasks as defined by Quality Assurance Leadership.

Education and Experience

Bachelor’s degree in life sciences, medical technology, or related field.
Minimum 4 years of experience in a central lab or clinical trial lab environment, with at least 2 years in a quality management role, or an equivalent combination of education and experience.
Professional quality certifications are optional.

Skills and Ability

Strong understanding of the CFRs, CLIA, CAP checklists, GCP, and ICH guidelines as they pertain to clinical trial operations.
Strong understanding of the clinical laboratory and clinical trials environments.
Excellent communication, leadership, analytical, organizational, and interpersonal skills.
Ability to independently manage responsibilities and apply deep subject matter expertise to solve complex problems and guide decision making.
Ability to read, analyze, and interpret technical procedures, professional journals, and governmental regulations, and to write reports, business correspondence, and procedures.
Ability to effectively present information and respond to questions from groups of managers, clients, and auditors.
Ability to apply concepts of basic algebra and statistics to quality data and trend analysis.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists, and to interpret instructions furnished in written, oral, diagram, or schedule form.
Working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, and Project. Experience with eQMS (e.g., Veeva), eLMS, document control, and other industry software preferred.

Supervisory Responsibilities: None
Physical Demands:
While performing the duties of this job, the occupant is regularly required to:

Prolonged periods of sitting at a desk and working on a computer.
Prolonged use of computer and headphones for conference calls.
Communicate effectively via phone, video, and email.
Use hands and fingers to operate a computer and other office equipment.
Sit 75% of the week.
Stand 25% of the week.
Walk and/or reach with hands and arms 15% of the week.
Read text of various sizes.
Communicate with others and hear.
Lift, pull and/or push up to 25 pounds.

Work Environment: Office environment; noise level is usually moderate.
Travel Requirements: Minimal