Senior Director, Global Quality Systems
At ProClinical, we are seeking an individual to fill the role of Senior Director of Global Quality Systems, based in Pennsylvania. This position is responsible for the development, direction, execution and compliance of GxP Corporate Quality Systems, in compliance with all appropriate quality regulations and standards of practice.
- Develop and oversee the Quality Management System.
- Facilitate the development and maintenance of quality systems supporting pre-clinical, clinical, manufacturing and distribution activities.
- Oversee the design, development, roll-out and maintenance of Global GxP e-Quality Systems that includes system administration of electronic Document Management system and electronic Quality Management System.
- Ensure that the Quality Management System is maintained in accordance with current regulatory compliance requirements and meets current corporate quality and business objectives.
- Manage QA IT and Computerized System Validation groups.
- Develop and conduct the GxP training program, Inspection readiness programs, Internal/external audit program.
- Coordinate and conduct periodic Quality Management reviews.
- Define and compile quality performance and compliance metrics.
- Develop, establish, write and implement Quality Assurance SOPs and Forms as necessary.
- Promote Quality and GxP awareness across the organization including training initiatives and the development and maintenance of the Quality intranet web site.
Skills And Qualifications
- BA or higher, preferably in a scientific discipline.
- 10+ years' Quality Assurance in a Pharmaceutical environment. Global experience a plus.
- Knowledge of US, EU, ICH regulations, guidelines and requirements.
- Knowledge of GCP/GLP/GMP requirements for drug substance and drug product manufactured for use in clinical trials and commercial distribution.
- Functional understanding of the drug development life cycle from discovery through post approval.
- Knowledge of 21 CFR Part 11 and the equivalent international regulations and guidelines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 6468786308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.