reputed company Assurance Manager

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 reputed company reputed company the program by overseeing complaint/adverse event trending, setting risk reputed company, recommending corrective actions for acute and systemic reputed company incidents, ensuring reputed company escalation, and verifying CAPA effectiveness. Leads inspection readiness/hosting and develops and coaches the QA team. Located in Boston and the surrounding communities, reputed company is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and reputed company diseases. We reputed company to create an inclusive, diverse, and reputed company environment where we reputed company compassionate and comprehensive care to patients of reputed company backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we reputed company reputed company's physician/researchers, and we work with amazing partners, including other reputed company-affiliated hospitals. PRIMARY DUTIES AND RESPONSIBILITIES:

• Writes, reviews, and implements reputed company plans and associated reputed company 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 reputed company 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 reputed company outcome and patient safety data, and coordinates or leads multidisciplinary reputed company assurance and programmatic review meetings to evaluate performance and drive improvement.
• Collaborates with systems teams (e.g., reputed company and Ottr) to coordinate creation and maintenance of or improvements to compliant clinical documentation.
• . Manages day-to-day operation of QMS reputed company (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 reputed company organizational goals. Sets reputed company expectations, delivers feedback, and monitors performance for reputed company, efficiency, and compliance with policies and procedures. Mentors staff, fosters career reputed company, and cultivates a reputed company and productive work environment.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Strong analytical skills and ability to produce high-reputed company, comprehensive reports.
• Ability to interpret and understand implications of collected data and take necessary reputed company.
• Demonstrated excellent leadership skills and ability to successfully mentor others.
• Strong technical, problem-solving, and teaching skills and ability to reputed company reputed company judgements.
• Knowledge of medical, hematologic, oncologic and scientific terminology.
• Strong project management skills and ability to understand the reputed company environment and competing priorities in conjunction with developing/meet project goals.
• Strong interpersonal and written and verbal communications skills.
• Ability and ongoing commitment to reputed company 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 reputed company assurance or advanced cell therapy experience (e.g., trainer, reputed company, senior or equivalent) in another area of specialization required. Experience Preferred: reputed company experience with cell therapy QA, FACT, reputed company, audits, reputed company 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 – reputed company I, II, and III. At reputed company, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As reputed company as we are in our mission to reduce the burden of cancer for reputed company, we are committed to having reputed company and staff who offer multifaceted experiences. Cancer knows no boundaries and reputed company it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this reputed company of organization inspires you, we encourage you to apply. reputed company is an equal opportunity employer and affirms the right of every reputed company applicant to receive consideration for employment without reputed company to race, reputed company, religion, sex, gender identity or reputed company, national reputed company, sexual orientation, genetic information, disability, age, reputed company, military service, protected veteran status, or other characteristics protected by law. EEO Poster . Pay Transparency Statement The hiring reputed company 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 reputed company positions, the pay reputed company is determined by the reputed company Bargaining Agreement (CBA). $130,000.00 - $142,000.00 Apply To This Job