Quality Assurance Manager

The Quality Assurance Manager leads or participates in department specific quality improvement and quality assurance activities. Supports the design and implementation of new procedures and programs with respect to quality systems. Provides expert consultation in quality considerations and related technical aspects to program colleagues, senior administration, finance, Information systems, and research management on a requested basis. Is responsible for internal audits as outlined on the audit schedule and requested by department. May be recognized by outside agencies as the Quality Program Manager and represents department during audits by those agencies. Serves as knowledgeable expert on regulatory compliance relevant to the department. Plays a key role in identifying improvement needs and engaging others in the development and implementation of solutions in order to advance the value of the program or department. Supports or oversees staff training and competency to ensure compliance. Will serve as a back-up for other members of department management team and may supervise staff directly on an ongoing basis. Located in Boston and the surrounding communities, Dana–Farber Cancer Institute is a leader in life‑changing breakthroughs in cancer research and patient care.

PRIMARY DUTIES AND RESPONSIBILITIES:

Write, review, implement quality plans and associated quality systems (e.g., documentation, SOPs, training, audits, standardized treatment plans and consents) for assigned area of the program Perform periodic gap assessments against regulatory or accreditation agency standards and local SOPs Interact with outside agencies and external contracted partners as required for reporting events, coordinating inspections, providing subject matter expert opinions, maintaining licenses/certifications/memberships/registrations Responsible for the collection, assessment and reporting of data relevant to quality outcomes and patient safety metrics Collaborate with systems teams (e.g. Epic and Ottr) to coordinate creation and maintenance of or improvements to clinical documentation Coordinate and/or lead multidisciplinary quality assurance or programmatic review meetings Coordinate with other cell therapies groups for quality and patient safety concerns, and coordinate with internal DFCI resources for quality and process improvement May be assigned a role in research efforts aimed at improving clinical operations

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

Advanced knowledge of program, standard operating procedures, and regulatory requirements relevant to department Outstanding ability to engage staff in analytics and quality management, being able to teach and understand barriers to learning and change Demonstrated curiosity in seeking rational causes for performance problems, errors, deviations and systematic barriers to excellence Ability to coach staff when implementing needed changes for improving care Ability to perform effectively in a team based setting Excellent written and verbal communication skills SUPERVISORY RESPONSIBILITIES: May have direct reports

MINIMUM JOB QUALIFICATIONS:

Minimum Education: Bachelors degree in a related technical field required. Education in a clinical specialty, math, science, or engineering preferred. Minimum Experience: 7 years of quality assurance and cGMP working experience or 3 years internal experience as a QA/QI Specialist III or equivalent required. 2 years of direct report supervisory experience required. Experience in collaborating with pharmaceutical companies a plus. License/Certification/Registration: ASQ Certification recommended. Dana‑Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. EEO Poster Pay Transparency Statement 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). $132,500.00 - $146,300.00 #J-18808-Ljbffr Dana-Farber Cancer Institute