Senior Director, Quality
Job Title: Director, QA
Lead Department: QA
Reports to: Senior Director, Quality
FLSA Status: Non-Exempt
Sanaria Inc., a Rockville, MD based biotechnology company, offers a unique and challenging opportunity to join a world-class team to work on the development and commercialization of a live sporozoite-based malaria vaccine.
The Director of Quality will be responsible for further developing and optimizing the quality systems and quality assurance policies, programs and procedures in conformance with US and EMEA’s guidelines for GMPs for vaccine manufacturing. This position will work cross functionally with manufacturing, testing, facilities and validation team leads in effectively implementing an inspection readiness program.
Essential Duties and Responsibilities:
- Write, revise and implement QMS standard operating procedures
- Perform gap analysis of current quality programs and procedure to assess compliance to FDA and EMEA requirements
- Clinical Product release and COA generation
- Review and approve deviations, investigations, OOS and CAPA
- Perform effectiveness checks of CAPA and Change Controls
- Raw data review for GXP reporting
- Review and approve Change Controls
- Perform risk assessments of systems
- Perform internal audits and external audit
- Perform GMP training
- Implement a compliant training and evaluation program
- Manage and mentor the QA team
Work directly with the Senior Management to assure both continuous improvement of the Quality System and provide leadership for the overall Quality Management system.
Manage 2-5 technical professionals in the quality group.
Knowledge and Abilities:
- In depth knowledge of US and EU GMP’s
- In depth knowledge of USP and EP compendium
- In depth knowledge of aseptic and sterile product quality
- Prior involvement in establishing quality systems and experience in biologics/vaccines are preferred.
- Strong communication, project management, leadership skills and excellent written and oral English language skills are essential.
- The ability to work in a fast paced environment with multiple and competing priorities is essential.
Education, Work Experience and/or Licensure
Bachelor’s degree in a science-related field; chemistry, biology, microbiology, pharmacy, biotechnology required; MS preferred.
At least 10 years of experience in the pharmaceutical/medical device/diagnostic industry including at least 5 years as team lead or management experience in QA required. U.S. citizenship or permanent resident status is required.