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Director of Quality

ByHeart

ByHeart

Quality Assurance
Iowa, USA
Posted on Monday, December 11, 2023

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

Location: Allerton, Iowa

Start Date: ASAP

The Director of Quality directs and leads a team of individuals to ensure effective quality execution, continuous improvement, and infant formula regulatory compliance. Provide leadership within the facility to drive positive change through influence and example. This individual, in conjunction with plant operations, will build and maintain an effective culture of Food Safety and quality within the facility. Is responsible for developing and maintaining facility systems and processes that ensure finished product is food safe and meets finished product specifications. This person should be a highly organized effective communicator with an inquisitive mind with the capacity to investigate and lead solution-based decision making in the plant. This role is the most responsible Quality individual as Department Head and is part of the sites Senior Leadership Team.

Role Responsibilities

  • Drives quality ownership at all levels, collaborating with the organization to drive the right quality culture and mindset with our employees.
  • Develops quality systems, training programs, and expresses consistent, clear philosophies, and practices that align with Corporate Quality policy and ensures effective and efficient implementation across the organization.
  • Subject matter expert and thought leader on all aspects of Quality Assurance including cGMP compliance, Environmental Monitoring and Hygienic Zoning, Statistical Process Control, Continuous improvement, Laboratory Operations (including instrumentation and microbiology), PX Measures, procedural document control, release and stability testing protocols, root cause problem solving and new product development- quality assurance.
  • Leads USFDA inspections as most responsible quality individual and responsible for observation resolutions and close out with agency.
  • Directly oversees change management program to ensures compliance with related laws, regulations, and corporate directives.
  • Defines and implements facility processes in alignment with Plant Management to ensure finished product safety and quality, including : ensuring all records/documentation, procedures, manufacturing operations are in compliance with company and other relevant regulatory requirements for ingredients & packaging used and products produced.
  • Assists Corporate Quality and Supply Operations in the development of strategies to oversee compliance assurance at co-manufacturing sites, testing labs and warehouses
  • Provides business leaders with information and analytics when making key quality decisions.
  • Provides supervision for direct staff including hiring, training, performance management, mentoring and development.
  • Collaborates with Corporate Quality, Manufacturing Operations, Engineering, Maintenance, Procurement, and other Supply Chain support areas in order to efficiently implement Quality Improvement for Right-First-time product release.

Skills & Qualifications

  • Advanced ability to develop and manage Quality management systems and processes
  • Extensive Knowledge of USFDA regulation (e.g., 21CFR106, 107, 113, 117) and proven ability to develop applicable SOPs that are compliant to regulations and corporate guidelines.
  • Food Safety Preventative Controls experience is required
  • IQ, OQ, PQ and part 11 compliance understanding preferred
  • Experience in gathering data from a variety of sources, analyzing and interpreting complex problems, and utilizing effective decision-making skills to deliver superior business solutions preferred.
  • Demonstrated verbal and written communication of technical information. Working knowledge of laboratory information and quality systems required
  • BS in a Science-based curriculum (e.g., Biology, Microbiology, Food Science/Technology or Chemical Engineering) is required. Advanced degree is preferred.
  • Minimum of 10 years of USFDA Regulatory inspection experience
  • Minimum of 5 years of Quality leadership experience (i.e., Quality Assurance, Control, Compliance, or Improvement) within a manufacturing environment.
  • Minimum of 10 years in infant formula powder manufacturing, or other relevant food industry (e.g. Specialty Dairy Ingredients [Powdered] used in Infant Formula) required.

Physical Requirements

  • Need ability to stand, crouch and climb to perform adjustments to equipment, use ladders, and perform various types of manual labor.
  • Predominantly operates in an office environment.

Regulatory Requirements

  • Adhere to all safety policies and procedures, follow CGMP's, and work in a manner consistent with all corporate and regulatory, food safety, quality and sanitation requirements
  • Will comply with all applicable federal, state, and local standards for the manufacture of infant formula and other non-infant nutritional foods.

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.