Quality Assurance Manager

Overview

The QA Manager is responsible for day-to-day operation of the QMS at a program/site, including deviations/complaints, CAPA, change control, document control, training, metrics, and the internal audit program. Accountable for patient safety outcomes within the program by overseeing complaint/adverse event trending, setting risk thresholds, recommending corrective actions for acute and systemic quality incidents, ensuring timely escalation, and verifying CAPA effectiveness. Leads inspection readiness/hosting and develops and coaches the QA team.

PRIMARY DUTIES AND RESPONSIBILITIES

• Writes, reviews, and implements quality plans and associated quality systems for assigned program area, including documentation, SOPs, training, audits, standardized treatment plans, and consents.
• Counsels and trains staff in quality management practices.
• Conducts periodic gap assessments and coordinates process improvement activities to ensure compliance with regulatory, accreditation, and internal standards, in collaboration with internal stakeholders and cross-functional teams.
• Interacts with outside agencies and external contracted partners as required for reporting events, coordinating and preparing for inspections, providing subject matter expert opinions, maintaining licenses/certifications/memberships/registrations.
• Collects, analyzes, and reports quality outcome and patient safety data, and coordinates or leads multidisciplinary quality assurance and programmatic review meetings to evaluate performance and drive improvement.
• Collaborates with systems teams (e.g., Epic and Ottr) to coordinate creation and maintenance of or improvements to compliant clinical documentation.
• Manages day-to-day operation of QMS elements (deviations, complaints, CAPA, change control, document control, training, metrics) for the program/s. May be assigned a role in research efforts aimed at improving clinical operations.
• Supervises staff. Hires, develops, and manages staff to achieve organizational goals. Sets clear expectations, delivers feedback, and monitors performance for quality, efficiency, and compliance with policies and procedures. Mentors staff, fosters career growth, and cultivates a positive and productive work environment.

MINIMUM JOB QUALIFICATIONS

• Minimum Education: Bachelors degree
• Minimum Experience: 5 years of quality assurance or advanced cell therapy experience (e.g., trainer, lead, senior or equivalent) in another area of specialization required.
• Experience Preferred: Direct experience with cell therapy QA, FACT, NMDP, audits, outcomes data, SOP development and management, and collaboration with pharmaceutical companies strongly preferred.
• Licenses/Certifications/Registrations: ASQ or CPHQ Certification preferred
• Supervisory Responsibilities: Directly supervises QA/QI Specialists – levels I, II, and III.

PAY

$130,000.00 - $142,000.00 per year