Director, Quality Assurance - BioScience

If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now! Your Opportunity Our team members receive industry-competitive salaries and are eligible for great benefits packages: Competitive Pay Annual Bonus Earning Potential Comprehensive Health Insurance, Retirement Benefits and More Education benefit available to full and part time Smithfield team members on their first day of employment. Open to moving? We will help! Ask about our Relocation Assistance packages! In addition, we offer opportunities for career growth, professional development, and tuition assistance. The position is one of enforcing strict compliance with the current Good Manufacturing Practices (cGMP) at Smithfield BioScience's FDA registered facility. This position will be responsible for QA oversite in the manufacture of the company's active pharmaceutical ingredients (API) and medical device components following 21 CFR Parts 210/211, ICH Q7, ISO 22442, and EU guidelines. The Director of Quality Assurance will ensure the quality and integrity of the Company's products and quality management systems, including maintaining the systems with state-of-the-art controls and procedures. This position also supervises training and tracking of all company associates on appropriate SOP's related to their job responsibilities. Core Responsibilities Lead the QA team to ensure the Company's compliance with cGMP and adherence to all company SOP's. Develops and manages processes and procedures related to quality assurance of products. Ensures the accurate reporting, archival and retrieval of all relevant department data and activities. Leads and assigns technical tasks/duties associated with quality processes and procedures. Conducts internal and supplier audits and participates in customer and regulatory audits. Maintains the facility in a constant state of readiness for FDA or other national competent authority inspections Leads, safeguards, maintains, and monitors the Company's records pertaining to the QMS, including those from production, the laboratory, administration, and relevant development projects. Guarantees all the Company's products, packaging and labels are true and correct prior to dispatch. Partners with Smithfield Environmental to ensure compliance with EPA regulatory standards for wastewater and regulated plant activities. Coordinates critical change control activities with regulatory affairs to evaluate the impact to the Company's customers. Guarantee the Company's OOS, CAPA, Complaint, and Deviation investigations are performed in accordance with FDA standards and guidance documents. Collaborates with third party experts as needed. Stays current with FDA requirements as it pertains to manufacturing, the laboratory, and the Company's products Prepares and reports annual product reviews to the Quality Review Board. Collaborates with cross-functional groups to ensure necessary validations are performed for all relevant company processes, test procedures, and computerized systems. Provides leadership and decision making in managing situations and issues relative to quality. Leads continuous improvement of our processes and procedures. Regularly tracks data and monitors key quality objectives and reports them to senior site management. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilitie