MD Anderson Cancer Center Biologics QA Supervisor in Houston, Texas
The mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.
Biologics Product Development
Biologics, be it monoclonal antibodies (mAbs) or cell therapies are complex therapeutics that are revolutionizing the treatment of cancer and yet are difficult to robustly develop and manufacture. To unlock the potential of these modalities MDACC is investing in Biologics Development capabilities within TDD accelerate the results we have already achieved, with multiple programs currently in clinical development. The goal will be to develop industrial biologics with a commercial horizon within the innovative environment of an academic cancer center. The group will be a composite of industry veterans who are interested in applying their experience to develop innovative therapeutics and see them impact patients, as well as academics looking to turn science into products. We work in a fast-paced, milestone-driven environment with a focus on team science and interdisciplinary research. Our unique approach has created a biotech-like engine within the walls of the nation's leading cancer center to bring life-saving medicines to our patients more quickly and effectively.
The Biologics QA Supervisor will be responsible for the maintenance, tracking, and reporting of the Biologics Development Quality Management System elements and functions as the QA liaison to manufacturing, QC and facilities.
• Managing the established Quality Management System
• Leading quality for new projects including development of process, procedures and QC requirements.
• Supervise manufacturing quality production operations
• Ensure compliance to procedures and policies
• Provide expert knowledge of manufacturing process, utilities and equipment as related to quality requirements.
• Driving investigation processes related to deviations , CAPAs or Audits to successful resolution through close collaboration with Manufacturing, Facilities, CXOs, QC and Quality teams
• Manage project deadlines
• Participating in and leading quality in cross-functional team meetings
• Facilitating routine quality-manufacturing team meetings
• Determining accurate root causes of deviations and quality events
• Proposing and implementing effective CAPAs to eliminate these causes
• Performing CAPA effectiveness checks
• Managing document control activities
• Cross training within QA
• Drafting and/or revising SOPs and other controlled documents
• Assist in the implementation of quality management systems including validation of electronic systems.
• Developing validation/qualification deliverables including but not limited to: requirement documents, functional and design specifications, test protocols (IQ/OQ/PQ), and summary reports
• Assessing revalidation requirements and preparing recommendations and plans for such activities
• Lead quality efforts for the transfer of new equipment and processes
• Providing technical input to validation deviations; providing assessments for change requests on direct impact systems; and identifying qualification requirements to ensure the validated state is maintained
• Managing all troubleshooting efforts for procedural discrepancies
• Mentoring interdepartmental peers and management on the validation approach as required
• Reviewing and interpreting data for accuracy for completed validations/re-validations, and preparing report packages by analyzing and summarizing the data to support, test and protocol requirements
• Reviewing controlled documents relating to processes, cleaning, equipment, and computer systems validations
• Other duties as assigned
Required: Bachelor's degree in a related field.
Required: Five years of relevant experience to include two years of lead or supervisory experience. With Master's degree, four years of required experience to include two years of lead or supervisory experience. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience. Must pass pre-employment skills test as required and administered by Human Resources.
Preferred: Five years supervisory experience in a Quality Assurance environment, performing the tasks listed in key functions.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Requisition ID: 144955
Employment Status: Full-Time
Employee Status: Regular
FLSA: exempt and not eligible for overtime pay
Work Week: Days
Fund Type: Soft
Pivotal Position: Yes
Minimum Salary: US Dollar (USD) 85,000
Midpoint Salary: US Dollar (USD) 106,250
Maximum Salary : US Dollar (USD) 127,500
Science Jobs: Yes