Quality Assurance Systems Manager - BioScience

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A great job-and a great future-awaits you at Smithfield Foods. We're an $18 billion U.S. food company with nearly 60,000 employees worldwide. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Join our family today. 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.

This is a full-time position reporting to the Director Quality Assurance. As a Quality System Manager in the pharmaceutical industry, your primary responsibility will be to develop and maintain an effective quality management system (QMS) to ensure compliance with pharmaceutical regulatory requirements and industry standards. You will oversee quality control processes, manage audits, and drive continuous improvement initiatives to uphold product quality and safety. Additionally, you will collaborate with cross-functional teams to support regulatory submissions and maintain quality documentation.

Core Responsibilities

• Develop, implement, and maintain a robust quality management system aligned with relevant regulations and standards for active pharmaceutical ingredient (API) manufacture (e.g., 21 CFR 210/211, ICH Q7, FDA guidance documents).

• Establish and monitor quality objectives, metrics, and key performance indicators (KPIs) to evaluate the effectiveness of the QMS.

• Conduct internal and external audits to assess compliance with regulatory requirements and identify areas for improvement. Ensure timely resolution of audit findings.

• Collaborate with research and development, manufacturing, and regulatory affairs teams to ensure quality considerations are integrated into product development and manufacturing processes.

• Oversee the management of deviations, non-conformities, and corrective and preventive actions (CAPAs) to address quality issues and prevent recurrence.

• Implement and maintain robust document control systems, including procedures, work instructions, and quality records, ensuring their accessibility and accuracy.

• Lead risk management activities, including the identification, assessment, and mitigation of quality risks throughout the product lifecycle.

• Develop and deliver quality training programs to enhance employees' understanding of quality requirements, standards, and processes.

• Monitor and analyze quality data and trends to identify areas for improvement and drive continuous quality improvement initiatives.

• Stay abreast of regulatory changes, industry best practices, and technological advancements in the field, and update the QMS accordingly.

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 responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions.

• Bachelor's degree in a relevant scientific or engineering discipline (e.g., biotechnology, life sciences, chemical engineering) from an accredited four-year college or university and 5+ plus years of relevant experience in quality management in biotech or pharmaceutical industry.

• 2+ years of demonstrated experience in team management/development or project leadership is required

• In-depth knowledge of relevant regulations and standards in the pharmaceutical industry (e.g., 21 CFR Part 210/211, ICH Q7, 21 CFR Part 11).

• Strong understanding of Good Manufacturing Practices (GMP) and their application in the pharmaceutical industry.

• Experience in developing, implementing, and maintaining a quality management system.

• Experience in conducting internal and external audits and managing audit programs.

• Proficient with the TrackWise QMS modules for Quality Events, CAPA, OOS, and Audit (or equivalent eQMS system).

• Familiarity with risk management principles and tools, including FMEA (Failure Modes and Effects Analysis) and risk assessment methodologies.

• Excellent analytical, problem-solving, and root cause analysis skills, with the ability to apply data-driven decision-making.

• Strong written and verbal communication skills, with the ability to effectively interact with cross-functional teams, regulatory authorities, and external stakeholders.

• Relevant certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt are advantageous

EEO/AA Information

Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law.

If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

Salary Range