Manages the Clinical Quality Assurance System providing oversight to Clinical Standards development and maintenance, Clinical Audit Program, Good Clinical Practice Training and Clinical Inspection Readiness Program. The CQA group will also manage Quality System updates and provide day to day compliance assistance to Clinical Study Teams.
Provides support, direction and coaching to employees in the areas of GCP compliance.
Prepares for FDA and other regulatory agency audits and inspections.
Understands practical applications of GCP and a Risk based Quality approach. Writes and updates existing procedural documents to incorporate these approaches.
Tracks and Trends Clinical Audits and CAPAs.
Manages QA for Clinical Supply Master Labels for each study. Prioritizes work in alignment with company priorities.
Develops goals and objectives for the department in alignment with corporate goals and objectives.
Maintains Good Clinical Practice (GCP) at company.
Gives guidance and support to R&D, Clinical and other departments on data integrity and giid
Carries out direct supervisory responsibilities in accordance with the department-set goals. Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.
BS in Life Sciences or equivalent with 7+ years related experience within a pharmaceutical or Biotechnology Company.
CQA Management and hands-on CQA Operations and CQA Systems experience including supporting audits and inspections within pharmaceutical or Biotechnology Company. At least Six (2) years supervisory experience. Must be fluent in English language.
Additional technical experience in an area allied with GCP Quality, Quality Systems, 21 CFR Part 11, 50, 54, 56, 312, 314, and ICH E6 (R2) guideline. Experience with international clinical study compliance preferred.