Job Description

• Are you looking for a Director, Quality Assurance opportunity in a fast growing, Bio Services company
  
• You will have the opportunity to learn from external training, mentor ship, and cross-functional project teams.
  
• Plus, our advancement opportunities will allow you to realize your full potential. has a collaborative team environment where you will be challenged, rewarded and have fun!
  

In this role you will be responsible for:

• Plan and direct resources and activities of the quality and compliance functions.
• Develop and maintain product and service quality audit programs and GMP audit programs for the Maryland operations.
  
• Collaborate with operational and quality staff in other locations including Redwood City, CA.
  
• Manage the Quality System and support the quality functions of all critical operations including laboratories, clinical trials and manufacturing
  
• Direct application of the Quality Systems in assuring that components and finished products are in compliance with established specifications and regulations.
• Responsible for release of all products manufactured.
• Ensure that performance and quality of products and services conform to established company and regulatory standards.
  
• Host external regulatory agency and notified body assessments and inspections (example: FDA, ISO).
• Review and participate in issues and/or decisions related to assessments.
  
• Ensure a technical liaison between QA/QS and all other functional management groups in terms of operational objectives, with respect to QA/QS concerns.
• Ensure that quality assurance and compliance resources are capable of providing required consultation and input for new projects, product development and transfer, manufacturing and distribution.
  
• Participate in cost reduction and improvement programs.
  
• Serve as the site management representative, providing updates to the company leadership regarding status of the quality system, compliance status and performance relating to quality.
  
• Advise staff to help meet established schedules or resolve technical or operational problems.
  
• Plan, promote and organize training activities related to product/service quality, quality assurance, and compliance.
  
• Estimate and administer budget schedules and performance standards.
  
• Maintain an up-to-date knowledge in the techniques of quality, and in the company products and process technologies.
  
• Responsible for ensuring management reviews of the quality system are conducted.
  
• Maintains up-to-date knowledge of FDA & EU regulations and applicable worldwide standards and requirements.
  
• Coordinate annual training for Blood borne Pathogens, Hazard Communication, and Ergonomics.
  
• Maintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulations.
• Track the paperwork from cradle to grave at BBI Biotech and provide appropriate guidance to other sites.
  
• Implement and oversee a cohesive validation program for operation.
  
• Schedule and manage the review of process and equipment validations and re-validation in accordance with established Company policy.
• Compete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements.
  
• Work in conjunction with purchasing department to develop supplier partnership opportunities and ensure supplier qualification meet current Quality Standards and regulatory requirements.

Qualifications:

• Bachelor??s Degree in Physical, Biological Sciences, or technical/scientific discipline required, MS preferred
  
• American Society for Quality certification desirable.
• Experience interpreting and complying with GxP , CLIA, IVDD or MDD and
• Must be able to read, write, speak fluently and comprehend the English language.
• Minimum of 10 years of experience as a Quality Professional in the laboratory, medical device, in vitro diagnostics, or life science industry.