Cures Start Here. AtFred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first and largest cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Fred Hutch Therapeutic Products Program (TPP) encompasses two, distinct, clinical manufacturing facilities in support of Phase I/II clinical trials. Trials consist of both internal, faculty-driven protocols as well as external partnerships with peer institutions and industry partners.
The Cell Processing Facility (CPF) performs cGMP manufacturing activities for cell therapy clinical trials involving the selection, genetic modification, and ex-vivo expansion of stem cells, T-cells, and B-cells. The CPF works with both internal Fred Hutch investigators and external collaborators to manufacture cellular products in support of early phase clinical trials and development programs. Similarly, the Biologics Production Facility (BPF) performs cGMP manufacturing activities in support of Phase I/II clinical trials involving monoclonal antibodies, fusion proteins, plasmids, Lentiviral vectors and similar, mammalian and bacterial-based cultures.
Reporting to the Sr. Administrative Director of TPP (with a dotted-line reporting to the Chief Ethics and Compliance Officer), the responsibilities of the Head of Quality are to provide leadership, direction, and coaching to the site quality organizations. This individual will be responsible for leading the day to day Quality Operations for Quality Assurance, Document Control and Quality Control. Responsibilities include implementation and continuous improvement of policies, procedures and standards necessary to ensure compliance with Phase I/II GMPs. Additional responsibilities include team building, career development, assisting with financial reviews, establishment of annual budgets and identification and rollout of yearly goals and objectives and longer-term strategic plans for the departments.
The position will involve managing multiple staff members across the quality organization including direct-line supervision of Managers/Sr. Managers in QA and QC along with responsibility for Document Control personnel.
The successful applicant will interact on a daily basis with clinical trial sponsors, manufacturing, research scientists, project management, and senior members of Fred Hutch faculty and administration.
Specific responsibilities will include:
Provide senior leadership for the TPP Quality departments (QA and QC)
Demonstrate outstanding technical acumen, operational understanding and GMP compliance in the maintenance and continued expansion of both manufacturing facilities
Lead the CPF organizational initiative to become FACT Accredited (Foundation for the Accreditation of Cellular Therapy)
Lead the review of quality attributes and systems required to support expansion of the biologics facility to a new, larger location
Ensure cGMP compliance, as appropriate for Phase I/II clinical trials, in all areas of TPP
Provide technical support of compliance aspects in other Fred Hutch departments such as the Vaccine and Infectious Disease Division (VIDD)
Foster a culture of strong GMP compliance
Develop and lead a team that meets the QA/QC compliance needs of the operation
Ensure all staff maintains appropriate level of training and meets compliance standards
Establish and effectively manage project-specific and departmental annual operating budgets for QA and QC
Establish and maintain Key Performance Indicators relative to quality operations
Manage and lead partner/client audits and FDA inspections
Ensure supplier quality management is completed in
Oversee the conduct of internal audits in compliance with FDA guidelines
Build effective partnerships with department heads to help drive the business toward achieving company objectives
Use of strong communication and teamwork skills to build relationships with stakeholders
Evening and/or weekend work may occasionally be required based on project need
A Bachelor of Science degree in a scientific discipline including pharmaceutical, biologics, or related field
10+ years of relevant experience in the pharmaceutical or biotech industries or at academic institutions
Experience at FDA regulated manufacturing sites within Quality Operations with demonstrated knowledge of GMPs and compliance requirements
At least 5 years of direct supervisory experience of technical/quality professionals and in providing guidance, mentorship and support to direct reports so that they can best manage their teams and projects
Expert knowledge of FDA regulations, GMP systems and operational excellence required for the manufacture of therapeutic products
Demonstrated ability to perform long-term project planning with meaningful timelines and budget forecasting
Proven leadership and coaching skills with emphasis on people development
Ability to prioritize multiple tasks, work under various timeline pressures, and drive tasks to completion
Must be able to communicate effectively in a diverse team environment in support of team goals
Must demonstrate solid time management and organizational skills, with good verbal and written communication.
Experience with basic Microsoft Office software (Word, Excel, Visio, etc.)
Must be able to don and wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE)
Must have the ability to stand for long periods
A MS or PhD degree with equivalent professional or academic experience
Experience in cell therapy applications with T-cells and stem cells
Knowledge of FACT accredidation
15+ years of experience in Quality
10+ years of supervisory/management experience
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We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at [email protected] or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.