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Senior Director, Quality Compliance and Systems

New York, NY

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

  • 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.