Director/Sr. Director, Quality Assurance GMP
- Build quality system for company from scratch including strategies pertinent to GMP, GLP, GCP.
- Lead and mentor the GMP QA team to establish high performance behaviors and personal growth.
- Serve as a subject matter expert to guide the company on global QA compliance.
- Ensure all manufacturing controls are defined, functional, reviewed, measured and reported related to drug substance, drug product, and finished goods.
- Work with Regulatory Affairs consultants for compliance as therapeutics advance from pipeline to clinic.
- Interact with partnered CMO/CROs.
- Oversee and conduct audits of suppliers and CMOs, including testing laboratories, and distribution channels.
- Develop, report and act on Quality Metrics related to GMP activities and vendor performance.
- Report to CEO.
Requirements of the Director/Sr. Director, Quality Assurance GMP:
- Minimum of BS if life science related discipline degree in a scientific discipline.
- Must have experience creating, developing, optimizing quality systems from scratch in pharmaceutical setting. Ideally with large molecule/biologics.
- Experience working in GMP, GCP, GLP environment.
- Knowledge of local, state, federal, and international regulations pertaining to GMP and FDA regulations.
- Auditor training or certification.
- Any regulatory affairs experience is a plus.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.