Quality & Regulatory Affairs Director

The Quality & Regulatory Affairs Director will be responsible for overseeing the Quality Assurance (QA), Quality Control (QC) and Regulatory departments for all Kemin business units within the KCG., The position will ensure that the KCG business units manufacturing, testing and placing Kemin products on the market  meet all applicable certification and regulatory requirements, while maintaining the all required quality standards. This role will also oversee and direct all activities associated with  manufacture facility registration, GMP documentation, laboratory practices, and product registration processes within the R&D department, ensuring compliance with local and international regulations.

We Are Kemin 

We are visionaries who see things differently and are inspired by the world around us.  

We have been dedicated to using applied science to improve the quality of life for over half a century.   

We are a global ingredient manufacturer that strives to sustainably transform the quality of life every day for 80 percent of the world with its products and services.  

For over half a century, Kemin has been dedicated to using applied science to address industry challenges and offer product solutions to customers in more than 120 countries. Kemin provides ingredients to feed a growing population with its commitment to the quality, safety and efficacy of food, feed and health-related products to customers around the world.   

Established in 1961, Kemin is a privately held, family-owned-and-operated company with more than 2,800 global employees and operations in 90 countries, including manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, San Marino, Singapore, South Africa and the United States.

As a Kemin team member, you’ll receive…

·  A competitive financial package- in addition to your salary, we offer an uncapped bonus opportunity, 401k match program, and paid vacation and holidays.

·  Robust health and wellness support- we are proud to offer a fitness reimbursement (for your whole family!), an on-site fitness center, restaurant with seasonal fresh food options (and the ability to order food to bring home), and free fresh fruit in break areas- to name a few.

·  Continued learning opportunities- Kemin offers tuition reimbursement and recently launched a new corporate university with online and in-person training opportunities for growth and development throughout your entire career.

·  The chance to give back to our world- Through our foundation of servant leadership, we are proud to offer ample service opportunities, including paid time off to do so. Kemin has a valued corporate partnership with both The World Food Programme and Habitat for Humanity, in addition to many local initiatives.

·  Opportunities to support our valued educators- Kemin is a proud sponsor of the Iowa Governor's Stem Advisory Council where we fund annual teacher's awards. In addition, we have a robust internship and externship program, and frequently host student tours.

Quality Control and Assurance

1. Lead and manage the Quality Assurance and Quality Control departments - continuously assess systems and procedures in QA and QC to assure they comply with business directives and current industry practices.
2. Develop and maintain a comprehensive Quality Management System (QMS) that aligns with all relevant standards to ensure product quality and safety
3. Direct activities for audit management, including external third parties, customers, GMP/internal and complaint investigation for continuous improvement.
4. Provide expertise and leadership in PIP (new projects) and Engineering projects (changes within existing systems) including new equipment, facilities, and product introductions.
5. Direct activities of QA and Food Safety functions through subordinate managers, and supervisors.
6. Direct activities for all documentation management, including SOPs, forms, training records and human resources database administration such “My Kemin”.
7. Direct activities for raw material management, including sampling, inspection and supplier management (as required for specific manufacturing facilities).
8. Ensure that products are tested and released from the QC laboratories in an efficient and timely manner and in full compliance with Kemin procedures.
9. Provide direct contact with BU partners for all QC activities and maintain overall responsibility for all follow-up actions within the QC department.
10. Serve as site technical expert and leader to direct develop interpret and execute QC Laboratory business goals.
11. Continuously assess systems and procedures in the laboratory to assure they comply with business directives and current industry practices.
12. Evaluate and coordinate method transfers from RD to QC.
13. Identify method deficiencies and coordinate timely updates for methods that impact commercial and submission activities.
14. Provide expertise and leadership in QC projects including new equipment facilities and product introductions.
15. Direct activities of QC functions through subordinate directors, managers, and supervisors.
16. Drive continuous improvement initiatives to enhance product quality and efficiency.
17. Stay informed and knowledgeable  of industry trends, methods certification changes to maintain compliance.

Regulatory Compliance:

1. Responsible for national and international product registrations, monitoring and influencing regulatory changes, and ensuring regulatory compliance of product formulations, labels and literature.
2. Manage the product registration process, including preparation and submission of necessary documentation.
3. Assume regulatory compliance for Kemin products and develop regulatory strategies to achieve product registrations on a timely basis in a worldwide capacity.
4. Serve as official Kemin liaison to major regulatory agencies within China and globally as required.
5. Interact with Regulatory Affairs officials both internally and externally to assure the timely exchange of information.
6. Review and sign-off for all Marketing/Sales literature for Kemin products.
7. Responsible for final review and approval of all product formulas and product claims for Kemin.
8. Oversee product recalls for Kemin products.
9. Collaborate with cross-functional teams, including R&D, Operations, and Sales, to align quality objectives with business goals.
10. Communicate effectively with stakeholders at all levels, including external regulatory
11. Provide technical expertise and guidance to the R&D team to support the development of new products that meet quality and regulatory standards.
12. Engage with regulatory authorities during inspections and audits, representing the company's quality and regulatory position effectively.

Training and Development:

1. Develop and deliver training programs for staff to enhance their understanding of quality and regulatory requirements.
2. Evaluate performance of direct reports and make recommendations for personnel actions; motivate employees to achieve peak productivity and performance.
3. Develop a culture of excellence and long-term strategy for talent retention.
4. Develop and manage the QA, QC and RA budget and monitor expenditures throughout the year and provide input about the strategic plan to the executive team.
5. Encourages cooperation among team members. Creates team spirit and sustains the interest of the team in completing projects.
6. Plan, develop, organize, implement, direct and evaluate the organization's teams and performance.
7. Fully encompasses the characteristics of a Servant Leader and effectively fosters and encourages this behavior within the unit.
8. Hires and recognizes potential staff for other roles in the company (especially in the commercial area) and mentors them into these roles.

ENVIRONMENTAL CONDITIONS: Normal office conditions. 

TRAVEL: up to 50%  domestic and potential for international travel.

1. Master degree in Chemistry, Bio-Chemistry, Food Science, Animal Science or relative. Doctor degree is preferred.
2. Extensive in-depth knowledge and experience in quality assurance, quality control and regulatory affairs within feed and/orfood manufacturing companies.
3. Experience in RD (developing and launching products) as well operations and manufacturing activities..
4. In-depth knowledge of ISO standards (FSSC22000), FAMI-QS, National Standard of the People’s Republic of China Standards, Global Food Safety Initiative (GFSI), Hazard Analysis and Critical Control Points (HACCP), FDA regulations and other relevant industry standards.
5. Excellent leadership and people management skills.
6. International experience and solid written and verbal communication excellence in English & Mandarin.
7. Practical and tactical approach, hands on attitude, and strong delegation style in managing teams.

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