Quality Assurance Manager
The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.
The Quality Assurance Manager for the UCSD Advanced Cell Therapy Laboratory (ACTL) will have oversight of Quality management, design & change control, documents/records control and archival. This position will oversee facility and equipment qualification, facility cleaning qualification, environmental and personnel monitoring plan development and ensure that raw material management activities are established and in compliance. They will monitor QMS processes and direct corrective and preventive action (CAPA) activities as well as plan for process and assay qualification/validation. The QA Manager will also perform internal audits for compliance control and external vendor qualification.
This position uses experience with biotechnology product Quality processes and concepts to interpret highly complex and broad regulations, policies and guidelines. Manager will serve as expert in matters of Quality compliance issues. This position exercise judgement in evaluating complicated Quality-related methods, techniques, and systems to anticipate and identify problems, and to develop and implement the appropriate resolution. The QA Manager is the strategic developer of the Quality Management System and Policies, they will generate the overall Quality Plan and guidelines.
In addition, this position presides over internal quality audits, FDA audits, provides recommendations based on knowledge of laws, regulations, and guidance governing drugs, devices, and biologics for transition of production processes from research use to current Good Manufacturing Policies (cGMP) compliance. And this position is responsible for planning, coordination, monitoring and continuous improvement of processes and methods for producing investigational materials for clinical studies.
The cGMP facility has growth potential as volume and demand will increase over time. Supervises staff responsible for working with clinical and business departments to ensure compliance with healthcare and / or financial reimbursement meet licensing and accreditation requirements. May oversee staff assigned to an area of specialty and implements new methods and processes. Receives assignments in the form of objectives with goals and the processes by which to attain them.
• Bachelor's degree in clinical or related area, and/or equivalent combination of experience/training.
• Five or more years of quality assurance experience.
• Demonstrated ability to effectively supervise a team and to manage the complex workflow and multiple priorities involved with regulatory compliance in healthcare.
• Strong knowledge of hospital regulatory and compliance requirements, standards, analytics and reporting.
• Strong knowledge of human resources management policies, with the ability to train, monitor, evaluate, and document personnel matters and performance, and participate in decision-making on personnel actions.
• Strong analytical and critical thinking skills, with the ability to quickly analyze problems, determine appropriate level of intervention, and develop and apply effective solutions.
• Strong interpersonal skills for effective collaboration with all levels of management and staff, to promote continual survey readiness, successful compliance practices, and ongoing fulfillment of accreditation and licensure requirements.
• Strong written and verbal communication skills, with the ability to serve as an expert resource, to convey complex requirements in a clear and concise manner, and to produce comprehensive reports and analyses for a variety of audiences.
• Prior experience drafting, negotiating and adhering to consultant and vendor service agreements up to $200K - 1.7M/year.
• Experience working in a complex organization that may feature matrix reporting and/or multiple sites.
• PMP certification desirable.
• Extensive demonstrated knowledge of human stem cell growth.
• Employment is subject to a criminal background check.
• Must be able to maintain confidentiality.
• Must have the ability to travel to offsite collaborator and vendor locations.
• Must be able to work various hours and locations based on business needs.
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.
UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html