Director of Quality Assurance

Genocea Biosciences is recruiting for a Director of Quality Assurance to manage the development and implementation of Quality Systems to support early stage clinical activities including GCP and GLP activities, including a human immunology laboratory. These systems will cover both an internal bioanalytical testing program and GMP manufacturing and testing by external vendors. The areas of responsibility will include, but are not limited to the following:

• Review and approval of manufacturing documents and release of clinical supplies
• Responsible for coordinating the development and maintenance of the company quality manual, quality policies, and standard operating procedures (SOPs).
• Perform and coordinate internal and external audits
• Establish and manage the document control system and activities necessary to maintain company product documentation
• Coordinate risk management efforts
• Establish and coordinate the company’s training program 
• Ensure the implementation and maintenance of laboratory-related SOPs and the SOP review process
• Work with all functional area directors to insure that a uniform approach to Quality is established and maintained across the company.

Qualifications:

For the above activities, the incumbent must have a good understanding of the product development process for biological products in general, including the different stages of development and the requirements of the different functional areas represented on the project team. In addition, the following qualities are needed to support this position:

• Must have a minimum of a B.S. degree in a relevant scientific discipline and 5 years in biological product development, including experience with the transfer of products from research to development and clinical studies in a timely and quality manner.
• Minimum 5 years of experience in QA management in biologic products with vaccine experience highly desirable.
• Experience with setting standards and creating policies for a company Quality System.
• Must have a good understanding and experience with quality systems and quality requirements for early stage biological product development.
• Comprehensive knowledge of relevant FDA and EMEA regulations and guidance documents.
• Experience with quality oversight and auditing of external vendors in the GMP environment. 
• Ability to work as part of a team in a matrix environment
• Must be professional, dedicated, and detail-oriented
• Excellent oral and written communication, interpersonal, analytical, and computer skills.
• Strong organizational skills required, including good time management skills.
• Highly organized and able to work independently on multiple tasks in a fast-paced environment.