Director of Quality

Director of Quality

A company specializing in high level contract services management and biotechnology support to emerging companies in the field of cellular and biological therapeutics is seeking a Director of Quality. The successful candidate will provide the appropriate leadership and strategic and tactical input to effectively operate and maintain a quality system in the support of existing and new cellular therapy products. Specifically, this individual will be responsible for ensuring that personnel, methods, corporate policies and SOPs comply with local, state, federal and global requirements, regulations, GLP and GMP requirements.
REQUIREMENTS
Qualifications:

Minimum of a Bachelor’s degree in science or related life sciences field

Minimum of 10 years overall experience in Quality

Minimum of 8 years supervisory experience

Must possess a thorough knowledge and understanding of cGMP,GLP and principles of both QA and QC

Strong knowledge of FDA manufacturing/regulatory quality systems regulations, qualification and validation and facilities requirements

Experience in a Cellular Therapy Company preferable

Must possess a thorough knowledge of procedures and have extensive experience related to controlled document system management.

Must possess a strong experience base in product QC testing and release procedures/documentation

Must be detailed oriented and have excellent organizational skills

Must possess effective written and oral communication skills

Must be able to work in multi-faceted operation