Director of Quality



Quality Assurance
Portland, OR, USA
Posted on Wednesday, April 26, 2023

About ByHeart

ByHeart is a fully integrated baby nutrition company dedicated to empowering parents with choice: we want all parents to feel amazing about feeding.

We build each product from the ground up: a team of pediatricians, breast milk researchers and nutrition experts at the forefront of immune, cognitive, digestive and microbiome health inform our next-to-nature approach. We hand-pick the most wholesome ingredients from partners and farms that we consider family. We take pride in what we put in and in what we keep out of each recipe. ByHeart is only the 5th FDA-registered infant formula manufacturer in the US, and the only new infant formula brand to complete its own clinical trial in over 15 years. Our formula is blended in proprietary small batch process in our owned facility in Reading, PA with rigorous quality and safety controls. Parents deserve farm-to-formula accountability. Innovation isn’t easy, but we believe in a better feeding future.

With over $190M in pre-market funding, we take our investors and board members as seriously as we take our formula: they come from a vast landscape of expertise, ranging from life sciences development to consumer media and direct to consumer disruption, and more. We launched our Whole Nutrition Infant Formula in March 2022, and are advancing a pipeline of mom and baby nutrition products & markets to follow.

Please visit our site to learn more, and see some recent press on ByHeart:

Fast Company


NPR's Weekend All Things Considered

White House Roundtable including ByHeart with President Joe Biden


Marie Claire

Wall Street Journal

Gimme The Good Stuff

ABC News

About Our Culture

A committed team is (and always has been) the fuel that propels ByHeart forward. ByHeart is comprised of world-class doctors, seasoned formula experts, dedicated blendmasters, and passionate parents. Above all, we are people who believe in no-compromise nutrition, farm to formula accountability, parent partnership and net positive impact for babies (and their parents!), meaning all families (including those of our own ByHeart team) have the very best health choices – whenever and wherever they need them.

At ByHeart, we say people are our number one priority, but we want our actions to speak louder than our words: we offer a fully comprehensive benefits package to every employee on the team, plus flexibility to achieve personal work-life balance. Join us to empower parents with the very best nutrition choices for baby – from (even before) day one.

Essential Duties & Responsibilities

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.

  • 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.

Competency & Skill Requirements

  • 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

Education & Experience Requirements

  • 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.

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.