Cures Start Here. At Fred 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 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.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
Fred Hutch has organized its Cellular and Biological materials process development and GMP manufacturing resources into a Therapeutic Products Program (TPP) wityh a Quality Control and Quality Assurance function. The Quality Assurance department will manage the quality program associated with both GMP facilities and liaise with the Seattle Cancer Care Alliance quality assurance system. The Quality Assurance group is anintegralpart of the program providing oversight for all manufacturing protocols and managing the FDA relationship.We are seeking a GMP Quality Assurance Manager to provide direct management for our Quality Assurance department while reporting to the Director and Head of TPP Quality.
Act as manager for the Quality Assurance Shared Resource within the GMP Therapeutic Products program.
Manage five -seven full-time Quality Assurance employees providing support to internal investigator protocols as well as external collaborative partners.
Establish and ensure appropriate Quality Systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality improvement opportunities and prevention of quality issues
Ensure compliance with all quality policies and continuous quality improvement initiatives
Provide expertise and guidance in interpreting governmental regulations, agency guideline and internal policies to ensure site compliance
Provide coaching and mentorship to the Quality team, ensuring appropriate levels of accountability for quality decisions and clearly communicates cross-functionally within the organization
Manage all aspects of plant quality systems, including document control, deviations, CAPA, supplier quality, change control, in-process quality assurance, quality control (analytical and microbiology laboratories), finished product review and release
Hire and manage departmental personnel directly.
Work with other Quality/Compliance, Operations, Planning, Logistics, Purchasing and Finance managers and personnel to effectively create and support process and quality enhancement initiatives
Support an aggressive Quality Program, which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies
Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant
Make fact-based, scientifically sound, quality decisions regarding products manufactured at the facility within the requirements of cGMPs and applicable regulatory/industry guidance documents
Manage approval or rejection of starting materials, packaging materials, bulk and finished products per the appropriate regulations and site policies and procedures
Execute and maintain a clear quality vision and strategy for the site
Supply the highest level of internal and external customer service and measure this through the maintenance and communication of site quality metrics
Lead and/or support investigations
Author, approve and/review area quality deviations and investigation reports as appropriate
Ensure on-time completion of all corrective action items
Lead the application of appropriate quality technology tools to establish and maintain process capability, and support systems for current pharmaceutical manufacturing
Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment
Bachelor of Science in Chemistry or Biology, Masters degree a plus.
6 -10 years of experience within the pharmaceutical or biotechnology industry (preferred) or academic setting.
5 years of experience in the manufacturing of Biologics and/or Cell Therapy products
5 years in a managerial role managing a team(s) of quality individuals
Lean/Kaizen/Six Sigma working knowledge preferred
Experience in working closely with and establishing cross-functional teams for process improvement efforts
Experience in developing/documenting procedures
cGMP training experience
Project management experience
Expert knowledge of cGMP requirements
Prior experience in managing inspections performed by FDA and other regulatory authorities.
Thorough understanding of quality systems
Complete understanding and application of principles, concepts, practices and standards for testing performed in all QC laboratories
Expertise in the manufacture and control of finished pharmaceutical products, analytical analysis techniques and statistical quality control
Strong working knowledge of FDA requirements and guidance documents
Ability to use relevant software packages to process and analyze data
Ability to lead an organization during a period of organizational growth and change
Ability to establish timelines and accountability for Quality and Cross-Functional Team projects
Excellent written and verbal communication skills
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
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@example.com 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.