hero
Red Sea Ventures Portfolio
Red Sea Ventures Portfolio
54
companies
268
Jobs

Quality Assurance and Regulatory Compliance Manager

ByHeart

ByHeart

Legal, Quality Assurance
Iowa, USA
Posted on Friday, April 19, 2024

ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That’s why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby—no matter how they do it.

When we launched our Whole Nutrition Infant Formula in March 2022, we were the first new U.S infant formula manufacturer in 15 years. Since then, we’ve been leading the way in a lot of ways.

We’re…

  • The only U.S.-made infant formula to use organic, grass-fed whole milk
  • The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk—alpha-lac and lactoferrin—to our ingredients list
  • The first infant formula company to receive Clean Label Project’s Purity Award (and we test for 700 contaminants vs the required 400)
  • We ran the largest clinical trial by a new infant formula brand in 25 years—clinically proving our benefits vs a leading infant formula like:
    • Less spit up
    • Softer poops
    • Easier digestion
    • More efficient weight gain
    • Enhanced nutrient absorption
    • Longer stretches between nighttime feeds*

With >$250M in funding, we’re shifting the industry forward—and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of >275 people that stretches across the country.


We're proud to offer competitive, family-first benefits, including but not limited to:

  1. Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family.
  2. Flexible paid time off: plus 12+ company holidays, and 2 floating holidays to use at your discretion!
  3. 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time.
  4. Up to 6% 401(k) Match to help you plan for your future.
  5. Company equity for every employee: because when we succeed, we succeed together!

Visit our site to learn more, and check out some recent press on ByHeart:

*based on data from infants at approximately 4 months of age


Role Description

Reports to: Director of Quality

Location: Allerton, Iowa

Start Date: ASAP

The Quality Assurance and Regulatory Compliance Manager will be responsible for the establishment, maintenance, planning, directing and coordinating of programs, procedures and processes necessary for manufacturing food ingredients in accordance with local, state and national regulatory agencies. Will maintain an acceptable level of product safety and quality to meet specific customer requirements and company standards. Support and aid operations in making safe and quality products.

Role Responsibilities

  • Creating and reviewing regulatory compliance documentation.
  • Coordinating the creation, review and implementation of policies and procedures resulting from new laws and regulations.
  • Designing and coordinating the preparation and ongoing review of policies, procedures, training materials and other communication tools to ensure departments meet compliance requirements.
  • Filing regulatory reports and other documentation.
  • Coordinating rollout and training of new or updated policies and directives when required.
  • Develop and maintain HACCP procedures, SOP’s, SSOP’s, Food Safety Plans and other requirements for compliance with the Food Safety Modernization Act (FSMA).
  • Maintain the state certification as well as permits for processing.
  • Interface with all regulatory agencies’ PDA, FDA, as well as organic, koshering agencies, halal, and customers.
  • Lead in regulatory, customer and third-party audits and coordinates audit responses to all findings.
  • Conducts or manages internal audits on a regular basis necessary to confirm compliance to SQF and other applicable requirements to determine food safety and quality systems are being maintained and followed.
  • Oversight of Customer Complaint Program and issuance of a response to the customer.
  • Develop and maintain the Environmental Monitoring Program. Oversight and/or performance of indicator organism testing, preparation of composite samples and collection of environmental samples for 3rd party pathogen analysis.
  • Develop and maintain a pest control program in collaboration with a 3rd party provider.
  • Manage direct reports by setting goals and objectives and oversee execution of these goals and objectives. Manage and supervise QA laboratory activities and laboratory personnel, coordinating daily work activities and oversee instrument calibration and preventive maintenance programs as it relates to equipment used in the laboratory. Ensure compliance with written procedures.
  • Develop and implement methods and procedures for disposition of aged and non-conforming materials. Review and approval of all investigations related to out-of-specification results, non-conforming material reviews, and significant batch deviations.
  • Facilitate Supplier Approval Program for raw materials and direct contact packaging with responsibility for facility risk assessment and approval of each material.
  • Responsible for the development, implementation and maintenance of the Food Safety System and Quality Plan.
  • Oversight of completed batch record review and issuance of Certificates of Analysis.
  • Reporting to management on the effectiveness of the Quality Management System.
  • Champion effective Root Cause Analysis and provide oversight of the Corrective & Preventive Action Plan.
  • Champion continuous improvement in all Quality processes.
  • Must maintain HACCP certification status. Trained as PCQI and as SQF Practitioner.

Skills & Qualifications

  • Bachelor’s Degree in Quality or Food Science or related field is preferred with a minimum of five years’ experience in a Quality Control Laboratory and three to five years’ experience in Quality Management with demonstrated leadership experience within the field.
  • Demonstrated working knowledge of cGMP for Food, as well as good laboratory practices, testing methodologies and manufacturing practices as described in the Code of Federal Regulations (21CFR 117).
  • Demonstrated ability to understand and organize technical data for communications and analysis
  • Demonstrate excellent oral and written communication skills and possess good interpersonal skills.
  • The ideal candidate possesses certifications in HACCP, FSPCA Preventive Controls and SQF; and training in environmental monitoring, auditing and statistical process control.
  • Must possess good communication and possess the highest integrity in conducting business affairs. Must exercise maturity and sound judgment in all dealings and associations with vendors and customers. Must be able to work independently and to organize tasks and manage the workload. Ability to deal with problems involving several variables in standardized situations, while defending decisions in a knowledgeable and rational manner. Able to interpret customer requirements and government regulations and apply to BlendHouse products and processes.
  • Infant Formula or Food manufacturing experience preferred
  • This job requires the employee to be able to lift 50 lb./25 kg bags or drums during the batching and bagging process. Need ability to stand, crouch and climb to perform adjustments to equipment, use ladders, and perform various types of manual labor.

This role is eligible for relocation support for candidates requiring a move to Allerton, IA. Additionally, you will be eligible for a discretionary performance based annual cash bonus and to participate in our company’s equity program, plus our robust medical, dental, vision, retirement, and other benefits.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.