Associate Director for Quality Assurance - Cell Manipulation Core Facility

The Quality Assurance Director will provide the Cell Manipulation Core Facility with direction and leadership in the development, implementation and auditing of Quality programs to support regulatory and accreditation compliance with applicable requirements (GMP/GTP/FACT/JC and other industry standards) as well as federal and state laws, and ensure that clinical and laboratory operations meet the highest quality standards set by the organization. This position will interface with both inter and intra institutional departments and industry sponsors, as well as regulatory and accreditation agencies. This position also interfaces with accreditation and regulatory auditors as well as with clinical research and industry sponsors to develop positive working relationships and ensure that compliant objectives for cell and tissue processing are understood and met. This position works extensively with both inter and intra institutional departments to ensure that compliant and safe processes and policies are developed for manufacturing, testing and infusion of cellular products.

This position oversees a group of quality specialists who carry out a variety of functions as part of the quality program including; clinical and laboratory quality assurance, quality control, and quality improvement activities in the context of both standard of care and clinical research treatments as well as with cellular product development and technology transfers.

The position oversees and is responsible for the compliant execution of the following key areas for the department. This list of key quality systems below is a snapshot and not limited to:

• Change control including equipment, facility and information systems qualification, change control and maintenance
• Facility and Environmental Controls
• Process and Process Controls
• Labeling and label Controls
• Documentation of orientation, training and competency assessment
• Executions of contracts and agreements
• Process control & final product inspection for research HCT/Ps
• Safe product and material storage and transportation
• Deviation, occurrence, complaints, error, variance, non-conformance management
• Tracking and trending of patient adverse events, reactions and outcomes
• Internal and external assessments
• Process Improvement
• Safety initiatives

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.

1. This position works hand and hand with technical directors/leaders, but has the authority to terminate any operations, processes or individual actions that may be harmful to a patient/product.
2. Accountable to ensure that the department is adhering to the policies and procedures addressed in the Quality Assurance Program including but not limited to the departments key quality systems listed above. Works with CMCF leadership to provide direction for updates to the CMCF Quality Program for cellular manufacturing and laboratory testing services according to regulatory and accrediting organization requirements.
3. Responsible for presenting analysis of key quality metrics after staff has gathered, compiled, vetted and performed trend analysis of patient outcomes including engraftment and product related infusional toxicities, also assesses product quality trends and reports findings back to appropriate clinical staff. The Quality department staff must cross institutional boundaries to extract clinical data from DFCI/BWH/BCH and other institutions for the products that CMCF manufactures.
4. Is responsible for communicating the status of the quality system to management through the use of established internal metrics and reports. These include but are not limited to product quality, performance on various quality initiatives and regulatory and accreditation requirements.
5. Accountable for ensuring systems are in place to document and trend errors, accidents, deviations (planned and non-planned), out-of-specifications, biological product deviations, non-conformances and complaints. Responsible to track, trend and report to CMCF leadership, DFCI/BWH/BCH institute leadership and industry partners.
6. Responsible to develop and oversee system for reporting FDA reportable events as well as events through DFCIs safety reporting system.
7. Oversees the documentation systems, change control, and responsible to ensure that Good Documentation Practices are followed.
8. Assist CMCF Management Team in development and maintenance of GMP level SOPs, labels and related documents for all product processing.
9. Facilitates the periodic review of all laboratory manuals.
10. Responsible for the maintenance of files of superseded procedures, and maintenance of files of any pertinent documentation for new or revised policies and procedures
11. Change Control: Responsible to ensure that manufacturing processes, equipment, facility (clean rooms and labs) and systems are validated, and that a robust Change Control system and procedures are developed and maintained to meet state, federal, and international requirements.
    Collaborates with manufacturing on changes and ensures verification/validation activities are appropriately executed. Performs verification on research related products at key steps and at final release of the product.
12. Oversees recalls and post market surveillance, including product complaints.
    Responsible for overseeing the CMCFs staff training program to ensure documentation of employees training and competency assessments to meet operational, regulatory, and accreditation requirements. This include initial orientation, project based training and on-going assessments that are compliant with CLIAs five methods for assessment.
13. Internal and external audits:
14. Accountable to perform internal audits to assure compliance with goals and objectives set the department quality initiative, outside regulatory and accreditation requirements (JC, AABB and FACT standards, FDA regulations) and research protocols and IND/IDE documents.
15. Performs GAP analysis to ensure the department is compliance with all newly introduced requirements of regulatory and accreditation agencies to include: FACT, FDA, JC, AABB, CLIA, DPH and OSHA.
16. Performs external audits for services that CMCF contracts out to other facilities
17. Performs other duties as assigned.

Additional Duties and Responsibilities:

1. Has the authority to terminate any operations, processes or individual actions that may be harmful to a patient/product.
2. Attend safety training as required. Safety compliance: follow institution's safety procedures, wear PPE. Know, understand & adhere to all safety standards, i.e., emergency preparedness, chemical, infectious agents & radioactive hazards.
3. Professional Development: Annual CE & competency. Participates in the introduction and evaluation of new procedures, supplies and equipment.
4. Use resources (supplies, time, and people) in a responsible cost-effective manner

MINIMUM JOB QUALIFICATIONS:

1. Bachelors or advanced degree in science or related field, MT (ASCP) SBB desired. Five years minimum experience in the clinical laboratory or biotechnology with strong background in blood bank/hematology and marrow/stem cell manufacturing and experience and/or extensive knowledge in quality assurance/improvement, regulations and compliance.
2. Must be knowledgeable of FACT, FDA (GMP/GTP regulations, etc), AABB, JC, CLIA, OSHA and Massachusetts DPH regulations.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

1. Team player with excellent oral and written communication skills
2. Excellent organizational skills and strong understanding of Quality Assurance/Improvement.
3. Strong understanding of standards and regulation that govern the field of cellular therapy.
4. Thorough knowledge in the field of cellular processing and storage and in immunohematology,
5. Good technical and teaching skills, able to make sound judgment, good problem solving and analytical skills.
6. Resource / advisor responsibilities require in-depth knowledge and/or prior experience in cell processing.
7. Requires an ongoing commitment to upgrading of technical and supervisory skills.
8. Capable of working in a fast-paced environment, effective in a diverse work group, willing to work in a rapidly changing field.
9. Knowledge of the lab environment and ability to interact with patients, employees and management in a professional manner.

SUPERVISORY RESPONSIBILITIES:

Gives direction to all Quality Assurance Specialists and provides guidance to others in close collaboration with CMCFs Management Team.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

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 groups as protected by law.

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