Head of Regulatory Compliance and Quality Assurance

2 weeks ago

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

As the Head of Regulatory Compliance & Quality Assurance, you will be instrumental in delivering strategic oversight to global operations, ensuring alignment with corporate objectives.

Your key responsibilities encompass managing regulatory compliance and quality assurance for both in-house and outsourced product manufacturing, equipment production, and product application processes while cultivating a culture of quality and ongoing enhancement.

You will build and lead a high-performing team across Regulatory Compliance and Quality functions (including Quality Control), ensuring synergy with cross-functional teams to facilitate new product introductions and uphold regulatory compliance and quality in sustaining operations.

With your profound technical expertise, extensive experience in highly regulated sectors, and your collaborative leadership approach, you will formulate and execute effective Quality policies and practices, maintain adherence to regulatory standards, and establish robust relationships with regulatory bodies and clients.

What You’ll Do

Provide leadership and strategic guidance to the following global operations to achieve business objectives:

  • Product manufacturing (including handling and storage facilities and Contract Manufacturing Organizations) and product quality control.
  • Equipment manufacturing.
  • Product application.

Instill and motivate a culture of quality and continuous improvement throughout the organization.

Assemble and lead a high-performing team across all Regulatory Compliance and Quality functions that can scale with our rapidly expanding business.

Ensure close collaboration between the Quality function and 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 operational freedom.

Develop and implement streamlined and effective enterprise quality policies, practices, procedures, and technologies across the organization that ensure the integrity, compliance, and traceability of our products and services while enabling the organization to respond with agility, speed, and scale to evolving business needs and opportunities.

Collaborate with internal teams and external partners to ensure that quality standards and GxP (especially GMP) compliance requirements are met and sustained.

Establish and enhance 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 requirements.

Develop and monitor appropriate metrics to track performance and improvements.

Ensure the Company remains informed of all new compliance- and quality-related regulatory requirements and trends, providing guidance to senior management on the implications of any new or updated requirements.

Provide subject matter expertise and recommendations for resolving Quality-related issues.

Direct internal auditing, inspection, and recall readiness activities, coordinating efforts and leading interactions during regulatory agency or third-party inspections.

Build strong relationships with regulatory agencies, auditors, and clients.

Travel domestically and internationally to visit various sites and partners.

What You’ll Bring

A passion for Quality and for inspiring others to recognize its significance.

Bachelor's degree in a STEM or regulatory field (Chemistry, Biology, Biochemistry, Materials Science, Food Science, Process Engineering, etc.) is required.

Advanced degree in a STEM field or direct production/manufacturing/operations or process engineering experience is preferred.

8+ years of experience 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 various relevant regulated and third-party certified Quality schemes is required (e.g., GMP, GAP (Good Agricultural Practices), other GxP, FSMA, ISO, etc.).

Demonstrated experience in building and leading global Regulatory Compliance and Quality functions (including Quality Assurance and Quality Control) across a wide range 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 assessing and managing risk, taking a data-driven approach.

Experience with recall and crisis management.

Proven experience in 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 (commercial, technical, regulatory, and operational teams) and external partners to achieve shared objectives.

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 significant asset.

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