Director, Regulatory Compliance and Quality Assurance

5 days ago

California, United States Apeel Sciences Careers Full time

About This Role

As the Director of Regulatory Compliance & Quality Assurance, you will play a crucial role in providing strategic leadership to global operations, ensuring alignment with business objectives. Your responsibilities include overseeing regulatory compliance and quality assurance for in-house and outsourced product manufacturing, equipment manufacturing, and product application processes while fostering a culture of quality and continuous improvement. You will develop and lead a high-performing team across Regulatory Compliance and Quality functions (including Quality Control), ensuring collaboration with cross-functional teams to drive new product launches and maintain regulatory compliance and quality with sustaining operations. With your deep technical knowledge, extensive experience in heavily regulated environments, and your collaborative leadership style, you will develop and implement effective Quality policies and practices, maintain compliance with regulatory requirements, and build strong relationships with regulatory agencies and customers. Your passion for Quality and expertise in driving operational excellence will be instrumental in supporting Apeel's growth and success.

What You’ll Do

  • Provide leadership and strategic direction to the following global operations to drive the achievement of business goals:
    • Product manufacturing (including handling and storage facilities and Contract Manufacturing Organizations) and product quality control.
    • Equipment manufacturing.
    • Product application.
  • 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 that can scale with our rapidly growing business.
  • 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 to drive new product launches and maintain current freedom to operate.
  • Develop and implement “lean” and effective enterprise quality policies, practices, procedures, and technologies across the organization that ensure the integrity, compliance, and traceability of our product and services while allowing the organization to respond with agility, velocity, and scale to evolving business needs and opportunities.
  • Collaborate with internal teams and external partners to ensure that quality standards and GxP (especially GMP) (and other agency or third party) compliance requirements are met and maintained at Apeel and third-party locations.
  • 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, and provide guidance to senior management on the implications of any new or updated requirements.
  • Provide subject matter expertise and recommendations for the resolution of Quality-related matters.
  • Direct internal auditing, inspection, and recall readiness activities, coordinate activities, and lead interactions during regulatory agency or third-party inspections.
  • Build strong relationships with regulatory agencies, auditors, and customers.
  • Travel domestically and internationally to visit Apeel sites, customer sites, CMO sites, and vendors.

What You’ll Bring

  • A passion for Quality and for inspiring others to see and understand its value
  • Bachelor's degree in a STEM or regulatory field (Chemistry, Biology, Biochemistry, Materials Science, Food Science, Process Engineering, etc.) 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 (e.g., GMP, GAP (Good Agricultural Practices), other GxP, FSMA, ISO, etc.).
  • 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” -- tailoring, implementing, evolving, and scaling Quality best practices and processes to the market, size, and stage of the business.
  • 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, and a strong, external-facing representative of the organization.
  • Collaborative leadership style and strong interpersonal skills, bringing together internal (our commercial, technical, regulatory, and operational teams) 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.
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