FierceBiotech and FiercePharma Jobs
Quality Assurance Manager, CRO, Houston - Pharma-Cruiting - Life Sciences Executive Recruiters
Nov 03
Location: Houston, TXCategories: All Categories
Position Description
Quality Assurance Manager
Position Summary
Ensures compliance with Standard Operating Procedures (SOP’s) and FDA regulations.
Essential Responsibilities
• Supervises the Quality Assurance staff in the conduct of audits of clinical research studies.
• Reviews the analytical reports supplied by subcontracted laboratories, statistical reports generated by the Biostatistician and clinical reports written for FDA submission.
• Oversees the maintenance of current and archived SOP’s.
• Performs operational audits in the conduct of clinical trials for compliance to protocol, SOP’s and FDA regulations.
• Hosts audits and inspections by clients and regulatory agencies as needed.
• Provide SOP training and good clinical practices (GCP’s) training to staff.
• Provides technical expertise and direction ofsystems in the implementation of clinical trials.
• Identifies needs and ensures development for SOP’s for critical areas of operation.
• Ensures timely review and updating of current procedures.
• Provides consultation to the Institutional Review Board on regulatory issues for pending and ongoing trials as necessary.
• Directly supervises employees in the Quality Assurance Department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.
• Other duties as assigned.
Qualifications
• Bachelor’s degree and/or four years related experience or equivalent combination of education and experience.
• A minimum of 2 years experience managing a staff.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
• Ability to write reports, business correspondence and procedure manuals.
• Knowledge of spreadsheet, internet, project management software, database and word processing software.
Licensing/Certification Requirements
• No professional license or certification required.
Please email your cover letter and resume to ruth@pharmacruiting.com
