Full-Time

Quality Compliance Manager

Confirmed live in the last 24 hours

ByHeart

ByHeart

51-200 employees

Produces organic infant formula with patented blend

No salary listed

Senior

Allerton, IA, USA

This role is eligible for relocation support for candidates requiring a move to Allerton, IA.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • 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.
  • 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.
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.
Desired Qualifications
  • The ideal candidate possesses certifications in HACCP, FSPCA Preventive Controls and SQF; and training in environmental monitoring, auditing and statistical process control.
  • Infant Formula or Food manufacturing experience preferred.

ByHeart focuses on producing and selling infant formula that aims to closely mimic the nutritional profile of breast milk. Their formula features a patented protein blend made from organic, grass-fed whole milk, which is considered healthier than the skim milk typically used in other formulas. This product has undergone clinical testing and is designed to offer benefits such as easier digestion, reduced spit-up, softer stools, improved nutrient absorption, efficient weight gain, and longer intervals between nighttime feedings. Additionally, it supports brain and eye development, as well as immune and gut health. ByHeart differentiates itself from competitors by maintaining high quality standards, as evidenced by their Clean Label Project Purity Award, which involves rigorous testing for contaminants. The company's goal is to provide safe, nutritious, and high-quality infant nutrition products to support the health and development of infants.

Company Size

51-200

Company Stage

Late Stage VC

Total Funding

$349.2M

Headquarters

New York City, New York

Founded

2016

Simplify Jobs

Simplify's Take

What believers are saying

  • ByHeart raised $95M to support US manufacturing and retail expansion.
  • The company expanded retail presence by 200% into Walmart, Whole Foods, and Wegmans.
  • ByHeart's subscription model increased customer lifetime value by 24% in three months.

What critics are saying

  • Increased competition from new entrants like Bobbie in the infant formula market.
  • Potential backlash over globally-sourced ingredients amid a trend for local sourcing.
  • Regulatory challenges in the infant formula industry could impact ByHeart's operations.

What makes ByHeart unique

  • ByHeart uses organic, grass-fed whole milk for its infant formula.
  • The company's patented protein blend closely mimics breast milk.
  • ByHeart has received the Clean Label Project Purity Award for quality assurance.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

401(k) Company Match

Company Equity

Growth & Insights and Company News

Headcount

6 month growth

-1%

1 year growth

1%

2 year growth

8%
Femtech Insider
Apr 9th, 2025
ByHeart Secures $72M for Expansion

ByHeart, a New York-based infant nutrition company, has raised $72 million in funding. The company has expanded its retail presence by over 200% into Walmart, Whole Foods, and Wegmans, now reaching over 1,100 Walmart stores and select other locations. ByHeart controls its manufacturing in Pennsylvania, Oregon, and Iowa, crucial amid supply chain challenges. The funding will support further retail expansion and manufacturing operations.

Business Wire
Mar 4th, 2025
Ordergroove Powers ByHeart's Subscription Expansion, Driving 24% Growth in Customer Lifetime Value in Three Months

"We're honored that ByHeart has chosen Ordergroove to power their next wave of growth as they solidify their market leadership with innovation and true partnership to parents."

Business Wire
Dec 5th, 2024
CORRECTING and REPLACING ByHeart Appoints Denice Torres to Board of Directors, Strengthening Its Mission to Innovate Infant Nutrition

ByHeart, the next-generation infant nutrition company, proudly announces the appointment of Denice Torres to its Board of Directors.

Berks Weekly
Nov 3rd, 2024
$18.75M in RACP grants fuels growth and revitalization across Berks County

ByHeart, Inc. was awarded an additional $5 million to expand its infant formula manufacturing facility in Exeter Township.

WFMZ
Nov 1st, 2024
Schwank touts millions in funding for Berks redevelopment projects

ByHeart, Inc. - $5 million for construction, infrastructure upgrades and land acquisition to expand ByHeart's infant formula manufacturing facility in Exeter Township, equipping it for advanced production and packaging to enhance capacity, capability and efficiency.