Full-Time

Senior Director

Quality Compliance and Systems

Posted on 7/13/2024

ByHeart

ByHeart

51-200 employees

Produces and sells infant formula

Food & Agriculture
Healthcare

Expert

Remote in USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Requirements
  • Bachelor's degree in a relevant field required, advanced degree preferred
  • Extensive experience (10+ years) in regulatory compliance within the food, pharma or infant nutrition industry
  • Experience with manufacturing and control of powdered infant formula
  • Experience with aseptic processing and sterilization processes
  • Proven track record of successful engagement with regulatory agencies
  • Ability to effectively interact with and manage suppliers, consultants, regulatory agencies and other external partners
  • In-depth knowledge of local, national, and international regulations related to baby formula production
  • Strong leadership and interpersonal skills with the ability to influence and guide cross-functional teams
  • Excellent analytical and problem-solving capabilities
  • Exceptional communication skills, both written and verbal
  • Ability to present recommendations and solutions to executive leadership team
  • Detail-oriented with a commitment to maintaining the highest standards of quality and safety
  • Availability for up to to 30% travel required
Responsibilities
  • Leads and manages a team that oversees quality compliance and quality systems for Byheart, end to end scope from development, manufacturing and distribution of baby formula
  • Responsible for internal and external audits of ByHeart operations and distribution network to ensure compliance to internal and external requirements
  • Proactively partner with R&D and Operations to developing and maintaining best in class quality systems
  • Collaborates cross-functionally to drive quality system integration into product development processes
  • Responsibility for successful design, implementation and execution of any strategic quality system improvements
  • Effectively collaborates across all operational and commercial functions including suppliers, Third Party Manufacturers (TPM) to ensure product compliance to market, regulatory, and ByHeart requirements
  • Engages with external groups including Regulators, Key Opinion Leaders (KOL’s) and Industry Groups
  • Establish and maintain relationships with regulatory agencies, proactively engages with agencies to promote effective communication, interaction and collaboration
  • Maintains detailed understanding of regulatory landscape, responsible for implementing proactive strategy and policy change where appropriate
  • Develop and implement risk assessment frameworks to proactively identify and mitigate compliance issues
  • Drive continuous improvement initiatives to enhance regulatory compliance
  • Coordinate responses to regulatory inquiries and inspections, ensuring prompt information cascade
  • Share responsibility for all aspects of quality compliance ensure that there is no major supply disruption due to quality compliance or related issues
  • Develop and implement training programs to enhance regulatory awareness across departments
  • Lead crisis management efforts related to regulatory issues, providing guidance on swift and compliant resolutions
  • Ensures leadership continuity through talent management and succession planning to establish and maintain an industry leading quality compliance and systems team.

ByHeart produces and sells infant formula, focusing on providing a product that closely resembles breast milk. Their formula features a patented protein blend made from organic, grass-fed whole milk, which is healthier than the skim milk commonly used in other formulas. This product has been clinically tested and is designed to offer benefits such as easier digestion, reduced spit-up, softer stools, better nutrient absorption, efficient weight gain, and longer intervals between nighttime feeds. Additionally, it supports brain and eye development, immune health, and gut health. ByHeart stands out 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 ensure that infants receive safe, nutritious, and high-quality formula, contributing to their overall health and development.

Company Stage

Late Stage VC

Total Funding

$248M

Headquarters

New York City, New York

Founded

2016

Growth & Insights
Headcount

6 month growth

1%

1 year growth

0%

2 year growth

10%
Simplify Jobs

Simplify's Take

What believers are saying

  • ByHeart raised $95M to expand its manufacturing and production capabilities.
  • Increasing demand for organic products aligns with ByHeart's grass-fed whole milk formula.
  • The rise of e-commerce offers ByHeart opportunities beyond traditional retail channels.

What critics are saying

  • Competition from goat milk-based formulas like Kabrita could impact ByHeart's market share.
  • Reliance on globally-sourced ingredients poses potential supply chain vulnerabilities.
  • High costs of organic ingredients may affect ByHeart's pricing and profit margins.

What makes ByHeart unique

  • ByHeart uses organic, grass-fed whole milk, unlike competitors using skim milk.
  • The company's patented protein blend closely mimics breast milk's nutritional profile.
  • ByHeart has received the Clean Label Project Purity Award for high-quality standards.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

401(k) Company Match

Company Equity

INACTIVE