Quality Assurance Director

About us: 20bloc, Inc. (www.20bloc.com) is an early-stage biopharma company creating breakthrough protein-based drugs to save lives. We are developing a safe and effective hemoglobin-based oxygen carrier for first response, organ preservation and oxygen therapy. We value and encourage innovations through open-mindedness, hard work, and team interaction. We work collaboratively, are intellectual and hands-on.

Position Overview: We are seeking an experienced Quality Assurance Director with demonstrated expertise working in the pharmaceutical/biotechnology industries supporting clinical production. This individual will be responsible for establishing the Quality Management System (QMS) at 20bloc, Inc. This is an exciting opportunity to join a growing, expanding start-up in a full-time position on site in Thousand Oaks, CA. If this sounds like a good fit for you, we'd like to hear from you!

Key responsibilities:

• Establish and be responsible for the Quality Management System (QMS), including the development, implementation and maintenance of a Quality Manual, remediation actions as required, document control system, internal and external auditing, GMP training, investigation of deviations and product complaints, batch record review, compliance improvement projects, and PAI readiness/FDA interactions.
• Manage the functions of site compliance and regulatory assessment which may include quality engineering, training, regulatory assessments, internal and external auditing, complaints, deviations and CAPA programs. 
• Act as site FDA liaison during inspection and coordinate responses as needed.

Qualifications:

• Must be familiar with all aspects of facility design, construction, validation and operation for a cGMP-compliant facility, including: HVAC segregation, room pressurization/classification, flows of personnel, material, waste, utilities and equipment design and qualification, and security and access control.
• Bachelor’s degree in a natural or biological science, or equivalent, with a minimum of 10 years’ experience in the pharmaceutical and/or biotechnology industry supporting clinical production with experience in managing projects from start to finish.
• Technical writing and investigation skills, as well as ability and skill in analyzing, understanding, and presenting technical data.
• Strong communication skills and ability to effect action across the organization.

This position provides an excellent opportunity for a highly motivated, collaborative individual to apply their skills and experience in an early-stage biopharma company while contributing to the development of a groundbreaking therapeutic protein product.

We offer a comprehensive benefits package which includes:

• Medical, dental and vision plans
• 120 hours paid time off (PTO)
• 12 paid holidays annually
• 401(k) U.S. retirement savings plan
• Employee assistance program

20bloc is an equal opportunity employer and values diversity. We provide the same opportunities disregarding race, religion, color, national origin, gender, gender identification, sexual orientation, age, marital status, veteran status, or disability status.