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. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
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
- Performs periodic gap assessments against regulatory or accreditation agency standards and local SOPs
- Interacts 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
- Collaborates with systems teams (e.g. Epic and Ottr) to coordinate creation and maintenance of or improvements to clinical documentation
- Coordinates and/or leads multidisciplinary quality assurance or programmatic review meetings
- Coordinates with other cell therapies groups for quality and patient safety concerns, and coordinates 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 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.
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