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Director of Regulatory Compliance and Quality Assurance

1 month ago

Santa Barbara, California, United States Apeel Sciences Careers Full time
About This Role

Apeel Sciences Careers is seeking a highly skilled Director of Regulatory Compliance and Quality Assurance to join our team. As a key member of our leadership team, you will be responsible for providing strategic leadership to our global operations, ensuring alignment with business objectives. Your responsibilities will include overseeing regulatory compliance and quality assurance for in-house and outsourced product manufacturing, equipment manufacturing, and product application processes.

Key Responsibilities
  • Provide leadership and strategic direction to global operations to drive the achievement of business goals.
  • Instill and inspire a culture of quality and continuous improvement across the organization.
  • Build and lead a high-performing team across all Regulatory Compliance and Quality functions.
  • Ensure close collaboration between the Quality function with R&D, Regulatory Affairs, Engineering, Manufacturing and Supply Chain, Sales, Field Operations, Marketing, and other cross-functional teams.
  • Develop and implement lean and effective enterprise quality policies, practices, procedures, and technologies across the organization.
  • Collaborate with internal teams and external partners to ensure that quality standards and GxP compliance requirements are met and maintained.
  • Establish and improve formal risk assessment processes to identify compliance and quality risks and appropriate mitigation strategies.
  • Oversee the investigation of quality incidents, deviations, and complaints, ensuring timely resolution and corrective actions.
  • Maintain existing product-related registrations and permits.
  • Support global trade compliance needs.
  • Develop and monitor appropriate metrics to track performance and improvements.
  • Ensure the Company is kept up-to-date with all new compliance- and quality-related regulatory requirements and trends.
Requirements
  • Bachelor's degree in a STEM or regulatory field required.
  • Advanced degree in a STEM field or direct production/manufacturing/operations or process engineering experience preferred.
  • 8+ years of experience working in a heavily regulated environment, preferably in the food, food additives/flavorings, or agricultural inputs industries, with 4+ years of leadership and management experience.
  • Experience in a high-growth or turnaround business setting is preferred.
  • Extensive knowledge of and experience implementing and ensuring compliance with a variety of relevant regulated and third-party certified Quality schemes is required.
  • Demonstrated experience building and leading global Regulatory Compliance and Quality functions (including Quality Assurance and Quality Control) across a wide breadth of operations from the ground-up.
  • Prudent in judging and managing risk, taking a data-based approach.
  • Experience with recall and crisis management.
  • Proven experience developing and leading a high-performance team.
  • Member of an active, reliable, and robust network of global regulatory compliance and quality contacts and resources to support changing business needs.
  • Collaborative leadership style and strong interpersonal skills, bringing together internal and external partners to achieve shared goals.
  • Strong technology and software proficiency and acumen, including ERP and other Quality data management systems.
  • Excellent verbal and written communication and presentation skills, attention to detail, organizational skills, and enthusiasm for process improvement and optimization.
  • English proficiency is required; Spanish language skills are a major asset.