Meet ByHeart

ByHeart is a fully integrated baby nutrition company dedicated to empowering parents with choice: we want ‘best nutrition for baby’ to be possible for every parent out there.

We build each product from ground up: a team of pediatricians, breastmilk researchers and nutrition experts at the forefront of immune, cognitive, digestive and microbiome health informs our next-to-nature approach; we hand-pick the most wholesome ingredients from partners and farms that we consider family; we take pride in what we put in and in what we keep out of each recipe; we blend in our own facility in Reading, PA with a proprietary small batch process to retain highest ingredient quality.

On track to become only the 4th fully-integrated, FDA-registered baby nutrition company in the US – and the only new brand with owned manufacturing and direct supplier relationships  – we just closed our over-subscribed $90M Series B in July 2021, and are about to launch our first infant formula, with a pipeline of mom and baby nutrition products to follow.

The ByHeart team is comprised of world-class doctors, pediatric researchers, seasoned formula experts, dedicated blendmasters, and passionate parents. Above all, we are people who know that innovation isn’t easy, but babies – and their parents – deserve a better feeding future.  

Please visit our site to learn more, and see some recent press on ByHeart:

Role Description

The position develops a lifecycle and systems-based approach to the design and implementation of Quality systems and process controls in conformance with regulation and corporate guidelines. Provides broad-based technical support and is solution focused in the oversite of quality events and deviations. The position will serve a broad spectrum of business units and functional areas, including procurement, marketing (e-commerce and retail), corporate development, finance, QA/QC, legal, environmental, health and safety (EHS), regulatory compliance, logistics and distribution at ByHeart and BlendHouse.

 

This role will allow the candidate to expand their experiences across and array of Quality topics that touch ByHeart.

 

Reports To:         Heather MacNaughton

Location:              Remote

Start Date:          January 31, 2022 or prior

 

Role Responsibilities

 

  • Accountable for managing and overseeing Quality Event resolutions throughout the ByHeart supply chain including the investigation process, root cause analysis through to the implementation of preventative measures as a result of production, complaints, and supplier events,
  • Ensures investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the corrective & preventive action.
  • Responsible for managing all CAPA effectiveness checks as an Infant formula Subject Matter Expert
  • Leads risk assessments for Byheart & ByHeart owned facilities and contract suppliers
  • Responsible for multiple Quality programs:
    • Supplier Approval Management (TraceGains System Administrator, and Supplier Audit Support),
    • Complaint Management (Trackwise System management/configuration, Triage, investigations, CAPA, Trending, Escalation, Customer Responses),
    • Quality production events and deviation investigation reports
    • Quality Customer Service (Specifications, Facility info, etc.) including Batch Record reviews and Release of product(s),
    • Management of the Document Control Program (Intelex System Administrator).
  • Establish implementation plan for strategic objectives to enhance quality systems compliance across ByHeart sites, incorporating integration of best practices.
  • Manage resources to ensure dispositioning of product is in conformance with requirements and meets site goals and needs.
  • Collaborate with other functional area goals and priorities by soliciting information from those functional groups during development of departmental objectives.
  • Make decisions based upon assessment of information from many sources including customers, manufacturing processes, QC testing, and other available information.
  • Provide strategic technical guidance and management support for quality functions minimizing workload, optimizing resources, streamlining existing systems, and contributing to continuous improvement opportunities.

 

Skills & Qualifications

  • BS - 10 years or equivalent at minimum
  • Minimum of 5 years of Regulatory inspection experience
  • Process and system management experience
  • Detailed knowledge of Quality management systems and processes required •
  • Knowledge of FDA requirements and understand how to develop applicable SOPs that are compliant to applicable regulations
  • Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
  • Provides well written investigation and technical summaries (meets defined quality standards) which can be used in a regulatory inspection responses.

 

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.

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