Quality Compliance Sr Specialist

Quality Compliance Sr Specialist

PIC North America, a Genus company, has an exciting opportunity. We are looking for a Quality Compliance Sr Specialist to develop policies, procedures, and methods to evaluate and improve the quality of products, materials, components, and/or operations for our Porcine division. This position will assist with expanding the system already in place and help foster a "quality culture" throughout PIC. Additionally, this position will be responsible for improving the regulatory relations processes, including customer complaint, animal health, and adverse event reporting processes to ensure good data and good relations with regulatory agencies.

The successful candidate will take ownership, be detail oriented and results driven, collaborate broadly as well as work independently, and have excellent verbal and written communication skills. You thrive in a fast-paced diverse culture.

This position can be based onsite in Hendersonville, TN or remote in the U.S. The salary range for this position is $70,000 - $98,000 USD. The salary provided is a good faith estimate representative of all experience levels. Genus considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.

You Will

1. Build upon and comply with PIC Quality Management System standards, policies, and procedures.
2. Work with other teams, locally and globally, to improve knowledge and adherence to systems, policies, and procedures.
3. Document quality assurance activities with internal reporting and audits.
4. Expand the recording and tracking systems for CAPAs and then maintain the process.
5. Update and improve the customer complaint process to ensure capture of investigation as well as all proper documentation.
6. Work with R&D regulatory team to build and maintain/own adverse event reporting processes.
7. Work with the Health Assurance team to continually improve health monitoring and reporting processes, including reporting to FDA and other external agencies.
8. Assist the broader Quality Management team with document control including document creation and revision.
9. Support regulatory submission questions and any external agency inquiries, which may require presence for external audits.
10. Conduct routine internal facility inspections, record audits of production barns, and discuss findings with site manager to ensure compliance.
11. Mentor peers in the application of Quality Culture, including Risk Management requirements and industry best practices.
12. Provide training and support to operations on systems, policies, procedures, and core processes.
13. Promote and maintain a strong safety culture and follow all safety policies, procedures, and regulations. Identify and communicate workplace hazards and correct or seek assistance in correcting unsafe actions or conditions.
14. Uphold the Genus core values, mission, and vision.
15. Position may require work responsibilities outside of normal business hours.
16. Travel approximately 10-15% domestically.
17. Perform other projects and responsibilities as assigned.

Requirements

Basic Qualifications: (required)

• A University Degree
• A minimum of 2 years of experience working in a Quality Management System
• A minimum of 2 years of experience in Microsoft Office applications, including SharePoint.
• Authorized to work in the U.S. without sponsorship

Preferred Qualifications:

• Regulatory experience
• Change Management experience
• Professional certification, such as Lean/Six Sigma
• Basic porcine/animal agricultural background

Business Overview

Genus is an agricultural biotechnology pioneer. We are a global FTSE 250 company, headquartered in the UK, and listed on the London Stock Exchange. Genus PLC has a presence in over 70 countries and a global workforce of over 3,000 employees and growing. We are a worldwide leader in porcine and bovine animal genetics, partnering with farmers to transform how we nourish the world a mission that is important to a sustainable future.

PIC currently supplies over 70% of the world's top pork producers. We directly employ people in 18 countries worldwide and our products are available in more than 50 countries across the globe. We are a diverse team, ranging from scientists to sales teams, production personnel to customer service, and are all united by a passion for producing nutritious, affordable pork and a commitment to continuous improvement.

Our vision is clear: Pioneering animal genetic improvement to help sustainably nourish the world.

Benefits Overview

At Genus we offer a competitive salary. Benefits include health, dental, vision, FSA/HSA, long and short-term disability, 401K, tuition reimbursement, paid holidays, and ETO (employee time off). This position will have opportunity for growth.

Equal Employment Opportunities

Genus is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Genus prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Genus conforms to the spirit as well as to the letter of all applicable laws and regulations.

Recruitment Fraud Warning

Genus plc will never ask you to provide fees or payment for computer, software, or other equipment or supplies during the recruitment and/or onboarding process. If you have any questions about your individual application, please contact the Genus Talent Acquisition team at View email address on click.appcast.io.