Certified Food Safety Director/Manager

Folium Biosciences LLC

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CERTIFIED FOOD SAFETY DIRECTOR /MANAGER

JOB DESCRIPTION

Summary/Objective

The Food Safety Director/Manager is responsible for the development and implementation of quality programs associated with FDA FSMA regulations. This individual will provide strategic direction and guidance for manufacturing, quality systems, suppliers, and raw material processes. Reports to the Chief Scientific Officer.

Essential Functions/Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Provide strategic direction and guidance for the implementation and adherence of all quality programs at manufacturing facilities (contract and internal as applicable), warehouses and raw material suppliers.
  • Manage and be accountable for the relationship with external manufacturing quality departments and monitor performance against Folium Biosciences, LLC procedures, product specifications, and relevant Key Performance Indicators.
  • Audit and review contract manufacturing Partners’ facility and quality systems to ensure compliance to Folium Biosciences, LLC Food Safety Quality Assurance expectations.
  • Work in Partnership with site Quality contacts to resolve quality issues and complaints in a timely manner. Manage the Corrective Action process, including review, trending and continual adherence to all CAPAs related to food safety and quality. Work closely with the product development team to ensure food safety requirements and quality standards are incorporated to the development process. Provide support during plant trials and production runs for product launches. Coordinate any required testing, product launch, and new Partner on-boarding related activities.
  • Act as a Food Safety Team leader for internal manufacturing as needed.
  • Lead design, creation, and implementation of Folium Biosciences, LLC Corporate and Manufacturing (Internal and External) Quality Management Systems by working cross-functionally with internal and external Partners to achieve and maintain relevant compliance standards.
  • Provide ongoing management, serve as an administrator, and drive continuous implementation for all applicable electronic databases and software related to Food Safety Quality and provide the appropriate training to all relevant stake-holders.
  • Facilitate in the development of all on-site employees to ensure their knowledge and implementation of food safety guidelines is up to date and exceeds compliance of federal and Folium Biosciences, LLC's regulatory guidelines
  • Manage internal Food Safety and Quality controlled document systems, nonconformance, CAPA, Change Control, internal audit activities, Food Safety Plan, Supply Chain Program, Food Defense Plan and other Food Safety and Quality related programs.
  • Develop product evaluation programs including quality scoring, gold standard, shelf life, etc. and tools to monitor internal performance metrics and drive continuous improvement.
  • Manage internal raw material and supplier review programs of which include risk assessment, review of key food safety & quality programs, and overall adherence to the FSMA and regulatory requirements.
  • Provide assessments of raw materials to ensure intended use of ingredients and regulatory status are suitable to their application in Folium Biosciences, LLC products. Ensure that these assessments are clearly communicated to all applicable internal and external stakeholders.
  • Work cross-functionally with key-internal stakeholders to ensure that raw materials and suppliers are appropriately reviewed and screened in a timely manner relative to project timelines.
  • Work closely with the Quality Assurance Manager and R&D team to ensure food safety requirements and quality standards for raw materials and ingredients are incorporated into the development process and provide Food Safety and Quality support as needed.
  • Audit and review suppliers as necessary to ensure compliance to Folium Biosciences, LLC Food Safety and Quality Assurance expectations.

Competencies

  • Teamwork Orientation.
  • Technical Capacity.
  • Stress Management/Composure.
  • Ethical Conduct.
  • Communication Proficiency.
  • Customer/Client Focus.
  • Business Acumen.
  • Personal Effectiveness/Credibility.
  • Project Management.
  • Computer, keyboarding (35wpm), and processing skills.

Supervisory Responsibility

This position may have supervisory responsibilities.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8 a.m. to 5 p.m. Occasional evening and weekend work may be required as job duties demand.

Travel

This position may require travel 5% of the time.

Required Education and Experience

  • B.S. in Food Science, Microbiology, or similar degree with 5+ years of progressive food industry experience in food safety and quality assurance.
  • Excellent knowledge of 21 CRF Part 117
  • Experience in 21 CFR Part 111
  • 5 years experience in quality systems design and management.
  • Certified as a Preventive Controls Qualified Individual (PCQI) or comparable experience.

Preferred Education and Experience

  • Experience with auditing and training highly preferred.
  • Experience with and understanding of US regulations including FSMA.
  • Expertise in implementing and maintaining food safety and quality management programs
  • Experience deploying and/or managing automated systems for documents and data.
  • Strong ability to communicate effectively and comfortable working within a cross-functional team to set the gold standard for quality and food safety.
  • Confident in being the expert with the foremost responsibility of ensuring food safety which will require you to make business and quality decisions based on scientific, regulatory and quality evidence.

Work Authorization/Security Clearance

Must be authorized to work in the United States.

EEO Statement

Folium Biosciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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