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.
- 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.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: - Strong analytical skills and ability to produce high-quality, comprehensive reports.
- Ability to interpret and understand implications of collected data and take necessary action.
- Demonstrated excellent leadership skills and ability to successfully mentor others.
- Strong technical, problem-solving, and teaching skills and ability to make sound judgements.
- Knowledge of medical, hematologic, oncologic and scientific terminology.
- Strong project management skills and ability to understand the enterprise environment and competing priorities in conjunction with developing/meet project goals.
- Strong interpersonal and written and verbal communications skills.
- Ability and ongoing commitment to upgrade and learn new skills and adapt to change.
- Strong team player capable of working in a fast-paced environment, effective in a diverse work group, and willing to work in a rapidly changing field.
MINIMUM JOB QUALIFICATIONS: Minimum Education: Bachelor's 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.
License/Certification/Registration: ASQ or CPHQ Certification preferred.
SUPERVISORY RESPONSIBILITIES: Directly supervises QA/QI Specialists - levels I, II, and III.
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
$130,000.00 - $142,000.00
