Simplify Logo

Full-Time

Senior Director

Quality Compliance and Systems

Confirmed live in the last 24 hours

ByHeart

ByHeart

51-200 employees

Produces and sells infant formula

Food & Agriculture
Consumer Goods

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 infant formula that aims to replicate the nutritional profile of breast milk, using a patented protein blend made from organic, grass-fed whole milk. This formula is clinically tested and offers benefits such as easier digestion, enhanced nutrient absorption, and support for brain and immune health. ByHeart stands out from competitors by achieving the Clean Label Project Purity Award, which ensures rigorous testing for contaminants. The company's goal is to provide safe and high-quality nutrition options for infants.

Company Stage

Series B

Total Funding

$291.7M

Headquarters

New York City, New York

Founded

2016

Growth & Insights
Headcount

6 month growth

11%

1 year growth

16%

2 year growth

106%
Simplify Jobs

Simplify's Take

What believers are saying

  • The recent $95M funding round, backed by prominent investors, positions ByHeart for significant growth and expansion.
  • Acquiring an additional manufacturing facility will enable ByHeart to scale production and meet increasing demand for its infant formula.
  • The appointment of Amy Schulman as Chair of the Board brings experienced leadership, potentially driving strategic initiatives and industry influence.

What critics are saying

  • The competitive landscape of the infant nutrition market is intense, with established brands potentially overshadowing ByHeart's market presence.
  • Scaling production and maintaining quality standards simultaneously can be challenging, risking potential supply chain disruptions.

What makes ByHeart unique

  • ByHeart's patented protein blend, derived from organic, grass-fed whole milk, sets it apart from competitors who typically use skim milk.
  • The company's commitment to quality is evidenced by its Clean Label Project Purity Award, which involves rigorous testing for 400 contaminants.
  • ByHeart's clinically proven benefits, such as easier digestion and enhanced nutrient absorption, provide a compelling value proposition for health-conscious parents.