ROLE DESCRIPTIONWe'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 OfficerLocation :RemoteROLES & RESPONSIBILITIESLeads and manages a team that oversees quality compliance and quality systems for Byheart, end to end scope from development, manufacturing and distribution of baby formulaResponsible for internal and external audits of ByHeart operations and distribution network to ensure compliance to internal and external requirementsProactively partner with R&D and Operations to developing and maintaining best in class quality systemsCollaborates cross-functionally to drive quality system integration into product development processesResponsibility for successful design, implementation and execution of any strategic quality system improvementsEffectively collaborates across all operational and commercial functions including suppliers, Third Party Manufacturers (TPM) to ensure product compliance to market, regulatory, and ByHeart requirementsEngages with external groups including Regulators, Key Opinion Leaders (KOL's) and Industry GroupsEstablish and maintain relationships with regulatory agencies, proactively engages with agencies to promote effective communication, interaction and collaborationMaintains detailed understanding of regulatory landscape, responsible for implementing proactive strategy and policy change where appropriateDevelop and implement risk assessment frameworks to proactively identify and mitigate compliance issuesDrive continuous improvement initiatives to enhance regulatory complianceCoordinate responses to regulatory inquiries and inspections, ensuring prompt information cascadeShare responsibility for all aspects of quality compliance ensure that there is no major supply disruption due to quality compliance or related issuesDevelop and implement training programs to enhance regulatory awareness across departmentsLead crisis management efforts related to regulatory issues, providing guidance on swift and compliant resolutionsEnsures leadership continuity through talent management and succession planning to establish and maintain an industry leading quality compliance and systems team.Skills & QualificationsBachelor's degree in a relevant field required, advanced degree preferredExtensive experience (10+ years) in regulatory compliance within the food, pharma or infant nutrition industryExperience with manufacturing and control of powdered infant formulaExperience with aseptic processing and sterilization processesProven track record of successful engagement with regulatory agenciesAbility to effectively interact with and manage suppliers, consultants, regulatory agencies and other external partnersIn-depth knowledge of local, national, and international regulations related to baby formula productionStrong leadership and interpersonal skills with the ability to influence and guide cross-functional teamsExcellent analytical and problem-solving capabilitiesExceptional communication skills, both written and verbalAbility to present recommendations and solutions to executive leadership teamDetail-oriented with a commitment to maintaining the highest standards of quality and safetyAvailability for up to to 30% travel requiredAdditionally, 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.#J-18808-Ljbffr
