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Director, Regulatory Compliance and Quality Assurance Specialist
2 months ago
Apeel Sciences Careers is seeking a highly skilled and experienced Director of Regulatory Compliance and Quality Assurance to join our team. As a key member of our organization, you will play a crucial role in providing strategic leadership to our global operations, ensuring alignment with our business objectives.
**Key Responsibilities:**
- Provide leadership and strategic direction to our global operations to drive the achievement of business goals, including product manufacturing, equipment manufacturing, and product application processes.
- 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 Research and Development, 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 effective enterprise quality policies, practices, procedures, and technologies across the organization that ensure the integrity, compliance, and traceability of our products and services.
- Collaborate with internal teams and external partners to ensure that quality standards and Good Manufacturing Practices (GMP) compliance requirements are met and maintained at Apeel Sciences Careers 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 organization 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 Sciences Careers sites, customer sites, Contract Manufacturing Organizations, and vendors.
To be successful in this role, you will need to possess a strong background in a STEM field, with a Bachelor's degree in a relevant field such as Chemistry, Biology, Biochemistry, Materials Science, Food Science, or Process Engineering. An advanced degree in a STEM field or direct production/manufacturing/operations or process engineering experience is preferred.
**Key Qualifications:**
- 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.
- Extensive knowledge of and experience implementing and ensuring compliance with a variety of relevant regulated and third-party certified Quality schemes, including GMP, Good Agricultural Practices (GAP), and other Good eXchange Practices (GxP).
- Demonstrated experience building and leading global Regulatory Compliance and Quality functions (including Quality Assurance and Quality Control) across a wide breadth of operations, 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 and external partners to achieve shared goals.
- Strong technology and software proficiency and acumen, including Enterprise Resource Planning (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.
**What We Offer
Apeel Sciences Careers offers a comprehensive total rewards package, including comprehensive health plans, 401(k) matching, equity, flexible Paid Time Off (PTO), sick leave, paid parental leave, and more. Compensation for this role is expected to be between $160,000 and $185,000, depending on geographic locations, skills, experience, and other factors permitted by law.
