RESEARCH PROGS/SVCS, AST DIR 3, Director of Quality Assurance
University of Florida UFL - Alachua, FL

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Requisition Title
RESEARCH PROGS/SVCS, AST DIR 3, Director of Quality Assurance

Working Title
RESEARCH PROGS/SVCS, AST DIR 3, Director of Quality Assurance

Position number:

Advertised Salary:
Commensurate with education and experience.

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This position is located in Progress Corporate Park in Alachua, FL.




Job Description:
The incumbent will serve as the Center of Excellence Florida Biologix Quality Assurance Director, reporting to the Associate Director, CERHB . The position provides independent QA oversight, review and approval of Manufacturing, Facilities and QC activities and compliance with all appropriate regulatory requirements pertaining to Florida Biologix. Prime responsibilities include oversight of compliance and continuing quality improvement, supervision of QA staff, manufacturing, facilities and QC coverage, validation support, batch record review, QA change control, writing annual reports, document control, auditing. The director will work closely with all departments, the project teams; and assist in project planning and time-line development.

The Director is responsible for overseeing the maintenance and development of appropriate quality/compliance systems and processes related to the operation of a biopharmaceutical manufacturing and testing facility for phase 1 and phase 2 clinical trial materials. These systems and processes are required by U.S. FDA regulations. The systems and processes include review and approval of production and testing activities for clinical product release, control of testing, process and equipment changes, validation of facilities and equipment, the development and approval of product and material specifications, label control, the review and approval of all written procedures, records, etc, the maintenance of an electronic document management system, issuance and control of materials, including raw material receipt and release, part numbers and production lot numbers, issuance and control of batch records, test records and other documents as required for the operation of the facility, quality control laboratory, and the production and storage of materials. The Director also oversees and conducts internal and external audits and post-audit reviews as well as ensure that follow-up/corrective actions have been completed. The QA Director oversees and conducts investigations, directs the QA training program, monitors processes, and maintains interdepartmental communication to ensure timely document review, approval and implementation. Duties will include monitoring manufacturing operations, including documentation and product quality issues, lot release, cGMP compliance, review batch records, evaluate, process and system changes and acceptance criteria. Work with process development, QC, and Manufacturing to reduce preventable deviations.

Additional responsibilities include: Assisting in compiling regulatory filing documents and maintaining computerized files to support all documentation systems. Managing and maintaining documentation computer databases; Maintaining annual procedural review schedules and quality manual databases; Maintaining training files and databases. Deliver a cGMP training curriculum. Develop processes and systems to assure compliance with cGMPs, ICH , ISO and industry standards; and anticipate the introduction of new requirements.

Interact with clients and prospective clients, including all quality audits and other site visits. Participate in the development of project contracts, quality agreements, etc.

Other duties as assigned.

Minimum Requirements:
Master’s degree in an appropriate area of specialization and two years of appropriate experience; or a bachelor’s degree in an appropriate area of specialization and four years of appropriate experience.

This is a time limited position.

Preferred Qualifications:
Required/Desired Qualifications
A Masters Degree with 10 years in the biotechnology/pharmaceutical industry in a QA, QC or manufacturing capacity and working knowledge of cGMPs. Five years of supervisory experience. Experience with QA documentation systems and biopharmaceutical development.
Knowledge of ICH , USP , and FDA requirements is mandatory, and experience with internal and external regulatory agencies during inspection processes is an asset. Highly motivated, hard-working, multi-tasking. Must be able to speak, read, and write in English in order to analyze and review technical information and written reports and present information to internal staff, regulatory authorities and external clients/parties as necessary.
Familiarity with word processing programs and spreadsheets is mandatory, as is a capacity to follow written procedures. Outstanding planning, organization, communication, leadership skills. Proficient in the use of personal computers and MS Office programs.
Must be capable of applying cGMP concepts/requirements to evaluate product release using sound judgment skills and interpret quality standards for appropriate implementation and review. Prior experience preparing data summaries for IND and other regulatory submissions along with knowledge of current industry standards are strongly preferred.

Health Assessment Required:

Special instructions to applicants:
Monday through Friday, 8am to 5pm.

Overtime may be required to meet timelines including weekends, evenings, holidays.

Posting Date:

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Open Until Filled: