Head of Regulation, Food Safety and Compliance - Prolific Machines

The Position

We are looking for a mission driven individual to lead our regulatory, compliance and food safety initiatives. The successful candidate will have experience in developing and implementing food safety and quality strategies and be comfortable interacting both with all parts of the internal organization (from cell biology, tissue engineering, media development, bioprocess engineering, through to product development), as well as, external regulatory bodies. 

The successful candidate will be comfortable drafting the required documents for regulatory submission as well as ensuring food safety and compliance with all relevant food safety regulations, standards and quality guidelines. Whilst initially the candidate will be responsible for working independently, we are looking to hire an individual who can scale and manage a team of food safety specialists as we scale our process and transition towards production.  

Key responsibilities will include although will not be limited to:

Regulatory Affairs Responsibilities

• Leverage knowledge of existing precedent and food safety protocols to develop safety procedures that will ensure the safety of our product and meet regulatory requirements.
• Interface with regulatory bodies and present a comprehensive food safety and quality assurance strategy for regulatory approval.
• Manage the drafting and submission of all documentation required to gain regulatory from the FDA/ USDA for our first cultured meat product.

Food Safety and Compliance Responsibilities

• Develop and implement a comprehensive food safety and quality strategy for the organization
• Oversee the development and implementation of food safety and quality policies, procedures, and systems
• Leverage knowledge of HACCP, FSMA, GMPs, CIP, sanitary design, and total quality management principles or techniques to develop food safety procedures inclusive of: 
• Environmental monitoring and sanitation processes, 
• Supplier approval practices
• Product testing and release practices 
• End to end traceability
• Conduct internal audits to ensure compliance with all relevant food safety regulations standards and guidelines.
• Build, lead and manage the food safety and quality team

Requirements

• The regulatory environment for cultured meat is an evolving landscape, and therefore the applicant will have to be familiar with current precedent and protocols and be able to apply these to a novel food product.
• Expected to have 7+ years of experience in the development and implementation of food safety and quality assurance programs. Experience in drafting, submitting and/or reviewing FDA submissions within the food or biopharma industry preferred.
• Bsc, Msc or PhD in Biology, Biochemistry or related field preferred
• Be a Preventative Controls Qualified Individual (PCQI) or willing to become PCQI certified.
• Have detailed knowledge of HACCP, FSMA, GMPs, CIP, sanitary design, and total quality management principles or techniques. 
• Demonstrate technical knowledge of Food Safety, Food Processing (as related to meats), applicable USDA and FDA Regulations, CAPA/Root cause analysis, Food Allergens, Document Control, Customer Complaints, Crisis Management, Specification Development, Quality Standards, Quality Systems, Sanitary design and Environmental Monitoring.