ByHeart is hiring a
Remote Senior Director Quality Compliance and Systems
\nROLE DESCRIPTION\n\nWe'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.\n\nReports To: Chief Quality Officer\n\nLocation: Remote\n\nROLES & RESPONSIBILITIES \n\n\n* 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\n\n* Responsible for internal and external audits of ByHeart operations and distribution network to ensure compliance to internal and external requirements\n\n* Proactively partner with R&D and Operations to developing and maintaining best in class quality systems\n\n* Collaborates cross-functionally to drive quality system integration into product development processes\n\n* Responsibility for successful design, implementation and execution of any strategic quality system improvements\n\n* Effectively collaborates across all operational and commercial functions including suppliers, Third Party Manufacturers (TPM) to ensure product compliance to market, regulatory, and ByHeart requirements\n\n* Engages with external groups including Regulators, Key Opinion Leaders (KOL’s) and Industry Groups\n\n* Establish and maintain relationships with regulatory agencies, proactively engages with agencies to promote effective communication, interaction and collaboration\n\n* Maintains detailed understanding of regulatory landscape, responsible for implementing proactive strategy and policy change where appropriate\n\n* Develop and implement risk assessment frameworks to proactively identify and mitigate compliance issues\n\n* Drive continuous improvement initiatives to enhance regulatory compliance\n\n* Coordinate responses to regulatory inquiries and inspections, ensuring prompt information cascade\n\n* Share responsibility for all aspects of quality compliance ensure that there is no major supply disruption due to quality compliance or related issues\n\n* Develop and implement training programs to enhance regulatory awareness across departments\n\n* Lead crisis management efforts related to regulatory issues, providing guidance on swift and compliant resolutions\n\n* Ensures leadership continuity through talent management and succession planning to establish and maintain an industry leading quality compliance and systems team.\n\n\n\n\nSkills & Qualifications\n\n\n* Bachelor's degree in a relevant field required, advanced degree preferred\n\n* Extensive experience (10+ years) in regulatory compliance within the food, pharma or infant nutrition industry\n\n* Experience with manufacturing and control of powdered infant formula\n\n* Experience with aseptic processing and sterilization processes\n\n* Proven track record of successful engagement with regulatory agencies\n\n* Ability to effectively interact with and manage suppliers, consultants, regulatory agencies and other external partners\n\n* In-depth knowledge of local, national, and international regulations related to baby formula production\n\n* Strong leadership and interpersonal skills with the ability to influence and guide cross-functional teams\n\n* Excellent analytical and problem-solving capabilities\n\n* Exceptional communication skills, both written and verbal\n\n* Ability to present recommendations and solutions to executive leadership team\n\n* Detail-oriented with a commitment to maintaining the highest standards of quality and safety\n\n* Availability for up to to 30% travel required\n\n\n\n\nAdditionally, 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. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Swift and Senior jobs that are similar:\n\n
$75,000 — $100,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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