Senior Director, Quality Compliance and Systems
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:
- Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family.
- Flexible paid time off: plus 12+ company holidays, and 2 floating holidays to use at your discretion!
- 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time.
- Up to 6% 401(k) Match to help you plan for your future.
- 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:
- White House Roundtable: President Biden Meets with Infant Formula Manufacturers
- Business Insider: ByHeart Announces Published Data in a Scholarly Journal on Benefits of The Novel High Quality Protein Blend in Their Groundbreaking Next-Generation Easy to Digest Infant Formula
- Governor Wolf Press Conference: Gov. Wolf highlights state investment in ByHeart, first new formula manufacturer in 15 years
- CBS News: As parents scramble to find baby formula, a new manufacturer is seeing soaring demand
- Forbes: A Startup Wanted To Make A Better Baby Formula. It Took Five Long Years.
*based on data from infants at approximately 4 months of age
ROLE DESCRIPTION
We're seeking a highly skilled Senior Director of Quality Compliance & Systems to ensure our products meet the highest standards and exceeds regulatory expectations. The position is remote and has a broad objective of providing strategic leadership in Quality Compliance and building best in class Quality Systems.
Reports To: Chief Quality Officer
Location: Remote
ROLES & 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.
Skills & Qualifications
- 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
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.
