Quality Assurance Lead

About Us

Who doesn’t love meat? Summer BBQs and friends around the campfire enjoying a succulent, delicious burger, packed with protein. Yep, meat rocks. The only problem is meat comes with baggage—greenhouse gasses, environmental degradation, nutritional concerns, and the welfare of animals. But what if the meat we love could be a force for good, helping to reverse these challenges?

Omeat's mission is to pioneer game-changing solutions to the health, environmental, and animal-welfare challenges posed by animal agriculture. We’re developing a scalable approach to producing cultured meat – meat grown from cells, outside the animal -- that's every bit as delicious and nourishing as conventional meat.

We are led by Ali Khademhosseini, one of the top tissue engineers in the world, previously at Harvard and MIT for 16 years. We’re looking for team members who want to change history. Fellow visionaries ready to sink their teeth into one of the greatest challenges humanity faces, creating a new future -- a future full of hope with clear-running streams, teeming oceans, thriving wildlife, and healthy communities. Are you in?

The Role

The Quality Assurance and Compliance Lead will be the leader of Omeat Quality & Food Safety Department. The primary responsibility of this position is to develop, train and track our Quality Systems, Food Safety standards, and Federal and State requirements that are designed for all aspects of the process to ensure that we maintain a safe product with consistent quality. Our ideal candidate has extensive experience within the food manufacturing and or biotech industry.

Responsibilities

• Ownership and management of the Omeat Quality Management System, including process improvement initiatives, metrics to monitor effectiveness and management reviews.
• Provides technical compliance, quality oversight and support to the CTO in making quality decisions.
• Front room Lead for external and internal audits including preparation and coordination of Backroom personnel and activities.
• Lead/co-leads implementation of QA Policies, Standard Operating Procedures, Work Instructions, as applicable.
• Ensures ongoing site compliance to documented processes, current Good Manufacturing Practices, and applicable regulations/standards.
• Own the Quality System function including Deviation Management (Non-Conformances), CAPA, Change Control, and Risk Management processes.
• Management of Change Control process, including coordination of Change Control Review Board (CCRB).
• Management of the Quality Control Function.
• Ensures that departmental decisions and project plans such as those for staffing, development, organization, material efficiency, hardware acquisitions, and facilities are in line with the organization’s Quality plans and mission.
• Establishes and administers the quality departments budget.
• Presents periodic performance reports and metrics to the Executive team.
• Create and develop food safety plans and protocols for supplies, ingredients, along with developing controls for our final product.
• Management of Training Program and Records management.
• Performs other related duties as required.

Requirements

• Bachelor's degree in life sciences, engineering or a related field.
• Expertise in cGMP compliance, FDA guidelines, and international guidelines dealing with bioprocessing, food manufacturing and Quality Assurance, quality standards, policies and procedures is required.
• In-depth understanding of quality processes/systems (e.g., change control, event handling, CAPA), risk management and manufacturing control strategies is preferred with a good understanding of ISO regulations related to pharmaceutical and food manufacturing.
• Must have a minimum of 10 years of experience in manufacturing or assembly.
• Demonstrated people and technical leadership and building and developing high-performing technical functions and teams.

• Excellent organizational skills and attention to detail.

Additional Details

• Food manufacturing work environment (steam, heat, and cold). Working in a cold sterile laboratory environment.
• Flexible schedule while working an expected 40+ hours/week
• Reports to Chief Technology Officer
• Based in Thousand Oaks, CA
• Minimal travel anticipated

Benefits

• Health benefits (medical, dental, and vision coverage)
• Flexible vacation time
• 401(k) matching
• 16 weeks of 100% Paid Parental Leave