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Senior Manager, Quality Continuous Improvement & Release

ByHeart

ByHeart

Quality Assurance
Austin, TX, USA · San Francisco, CA, USA
Posted on Friday, March 8, 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: Senior Director of Quality Assurance

Location: Remote , NYC, PA, OR, IA

Start Date: Immediate

The Senior Quality Release Manager will be responsible for managing release of ByHeart base and final product consistently across the organization at all manufacturing sites. This role will work closely with quality, operations, and regulatory to ensure timely and appropriate release of ByHeart product and to develop analytics to promote continuous improvement of right the first the first time and release process.

Role Responsibilities

  • Develop consistent process and tracking tools for review and release of ByHeart product to ensure visibility throughout the review and release process.
  • Ensure consistent and timely release of products per BlendHouse internal, customer, or regulatory requirements.
  • Manage the release and disposition status in the defined electronic inventory and quality management systems.
  • Directly manage site Quality Release teams to ensure effective application of processes and procedures.
  • Support review of Master Batch Records for completeness including but not limited to Critical Control Points (CCP) records, production records, warehouse records, sanitation records, etc.
  • Implement systems and metrics to review current state and implement efficiency opportunities.
  • Support sites in management of sample shipment, submission, and turnaround time to ensure on-time report of testing results.
  • Present nonconformances and items impacting quality or food safety to the ByHeart Corporate Food Safety Committee.
  • Work with cross-functional teams to define and monitor product sampling and analysis requirements to ensure food safety and quality criteria necessary for product release.
  • Review and support closure of any Event Reports for findings, discrepancies, or Out of Specification results discovered during batch review process. Work closely with Quality Assurance and Compliance teams for investigation. Work with owning departments to ensure timely closure of Event Reports for releasing.
  • Issue Certificate of Compliance or Certificate of Analysis as designated by customer guidelines or internal requirements.
  • Make improvements to the release process and provide necessary training regarding record keeping and procedure implementation.
  • Manage Batch Records filing for the site, all related contract manufacturing, packaging locations, ingredients, and customer related products.
  • Coordinate with contract partners and review paperwork.
  • Participate in investigations relating to non-conforming events (including product complaints) driving to root cause(s) and effective resolution (corrective actions).
  • Actively support and participate in the internal audit program and support, as needed, in regulatory inspections (e.g. FDA and / or third-party audits / certifications (e.g. SQF, Kosher, Organic).
  • Assist in completing documentation including but not limited to: Event Reporting, Corrective Actions, Change controls, Hold Reports, SOP’s, and forms that meet Internal and Infant Formula Requirements.
  • Provide written report such as trending and aid in Event Reporting as required.
  • Comply with all policies and procedures of BlendHouse facilities and ByHeart.

Skills & Qualifications

To perform this job successfully, an individual must be able to perform each essential duty independently and satisfactorily. Performance will be evaluated on an annual basis. It is essential that responsibilities are performed correctly and accurately. Duties must be executed in a timely manner. The requirements listed below are representative of the knowledge, skill and/or ability required.

  • Bachelor's degree required in food science, microbiology, toxicology, biological sciences, or related field, preferred.
  • Two to five years of experience in food processing or pharmaceutical environment (dairy, spray drying, or Infant Formula preferred). One tothree years of management (supervisory or process related) experience.
  • Working knowledge of HACCP, Preventive Controls and SQF principles. HACCP and PCQI certifications are a plus
  • Familiarity with laboratory testing and reporting preferred
  • Ability to review processes and procedures, and utilize critical thinking and communication skills to relay opportunities for improvement, and coordinate execution of improvements and processes
  • Ability to generate reports and communicate key messages
  • Strategic and problem-solving mindset
  • Must be able to work independently in order to organize tasks and manage timelines and deliverables
  • Ability to manage problems involving several variables in standardized situations
  • Effectively communicates critical information regarding job responsibilities
  • Use of computer systems including but not limited to ERP System (Deacom), Microsoft Word, Microsoft Excel, PowerPoint, and Doc Control System (QT9)

The minimum annual salary for this position is $120,000 and the maximum is $150,000. The salary range for performing this role outside of New York City will differ. 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.