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Senior Director, Quality Compliance and Systems

2 months ago

Australia ByHeart Full time

Job Summary

We are seeking a highly skilled Senior Director of Quality Compliance and Systems to ensure our products meet the highest standards and exceed 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.

Key Responsibilities

  • Lead and manage 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 develop and maintain best-in-class quality systems.
  • Collaborate 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 collaborate across all operational and commercial functions, including suppliers, Third-Party Manufacturers (TPM), to ensure product compliance to market, regulatory, and ByHeart requirements.
  • Engage with external groups, including regulators, Key Opinion Leaders (KOLs), and industry groups.
  • Establish and maintain relationships with regulatory agencies, proactively engage with agencies to promote effective communication, interaction, and collaboration.
  • Maintain a detailed understanding of the 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 to 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.
  • Ensure leadership continuity through talent management and succession planning to establish and maintain an industry-leading quality compliance and systems team.

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 teams.
  • Detail-oriented with a commitment to maintaining the highest standards of quality and safety.
  • Availability for up to 30% travel required.

What We Offer

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.