Senior Director, Quality

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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.
  
  

The Senior Director, Quality Has The Responsibility For The Strategic Design, Implementation, And Management Of The Quality And Regulatory Systems For Smithfield BioScience Including The Following Areas

• Maintain strict compliance to pharmaceutical and medical devices standards to ensure regulatory, FDA, customer, and internal cGMP requirements by leading the Quality Control, Quality Assurance and Regulatory Affairs teams.
• Auditing and testing systems for in-process and finished products to ensure conformance to internal, customer, and regulatory requirements.
• Quality programs including supplier information, qualification, and auditing systems.
• Corrective and preventative action to ensure conformity with established standards.
  
  

The incumbent also leads interactions with Customers, Product Development, Sales and Supply Chain leadership to develop systems and standard operating procedures to meet internal and customer quality requirements.

The Senior Director, Quality works with Senior Leadership in the identification of strategic goals and plans, advises company management in FDA regulatory policy and program matters, and recommends appropriate courses of action, along with overseeing relationships with Customers to ensure accurate technical information, specifications and resolve customer complaints.

Core Responsibilities

• Designs and manages quality management and compliance systems that ensure optimum product performance and maintains leading knowledge in the biological pharmaceutical products field.
• Leads investigating and implementing corrective/preventative action for customer complaints, nonconforming products, and nonconforming systems.
• Develops and manages procedures and work instructions to ensure conformance to specifications, quality systems, and good laboratory practices.
• Maintains a close relationship with Operations and leverages R&D initiatives to facilitate quality products, and design and achieve quality goals.
• Manages the design and implementation of quality-related training programs for Quality Control, Quality Assurance, R&D, Regulatory Affairs and Operations personnel in performing required tests, decision making skills, statistical process control, and other areas as needed.
• Partners with HR and Operations to design effective training curriculums to meet best practices manufacturing processes.
• Leads setting direction and goals for company product quality, FDA regulation, cGMP, laboratory, facility and equipment cleaning.
• Prepares and maintains the company Drug Master Files (DMF) filings with the FDA.
• Participates as part of new project design team and reviews new products, product design and product packaging, and makes recommendations for product, pharmaceutical product safety and environmental compliance.
• Recommends, reviews changes, and oversees implementation, and documents any approved design changes that apply to commercial products. Works directly with customers to facilitate specifications, product design, quality systems, information exchange, non-conforming product, variances, and investigation.
• Sets direction for audits of in-process & finished products, facility housekeeping, and sanitation of assigned facilities. Manages these audits for outside manufacturers and suppliers as needed.
• Acts as Project Coordinator and/or Project Leader as assigned for special projects.
• Represents the Company, as directed by Managing Director, Business Operations, in discussions with customers, suppliers, auditors, and regulatory agencies of the county, state, and federal government (FDA, etc.).
• Establishes, prepares and manages necessary department budgets, operating and periodic reports.
• Initiates and handles personnel actions such as hires, transfers, promotions, discipline and terminations.
• Directs QC, QA, and RA Managers in the activities of their departments, creates safeguards and improves the quality and integrity of the Company’s products and enhances safety.
• Ensures compliance with all of the regulations that pertain to the company, and Chairs the Quality Review Board. Working with Federal, State, and Local regulatory agencies and personnel on specific issues affecting the Company i.e. working with such agencies as the FDA or European Medicines Agency (pharmaceuticals and medical devices)
• Directs the development and improvement of Standard Operating Procedures
• Directs the annual Company cGMP-audit to monitor and determine compliance
• Writes, reviews, and oversees validations pertinent to the company’s manufacture, controls, and business
• Authority to divulge the Company’s proprietary information to meet the Company’s regulatory requirements. Requires approval to commit the Company for supplies, capital items, and services
• Must meet and exceed FDA and industry standards, achieving best-in-class adherence and safety
  
  

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.

• Bachelors Degree in Analytical Chemistry or related field from a regionally accredited college or university and 12+ years’ experience in the pharmaceutical industry; or equivalent combination of education and experience, required.
• Minimum of 8+ years’ experience in a position of leadership to include team development and management within a manufacturing environment under FDA, required.
• Ability to uphold regulatory, company, and customer standards.
• Skilled at quality principles, pharmaceutical manufacture, Quality Management Systems (QMS), Statistical Process Control (SPC) and experimental statistics.
• Experienced with GFSI / SQF - SQF Expert Practitioner is a plus.
• Comprehensive experience with FDA Rules and Regulations.
• Knowledge of Inventory and Manufacturing software; Spreadsheet and Word Processing software; and major enterprise ERP(s)
• Ability to independently respond to inquiries or complaints from customer, regulatory agencies, or members of the business community. Strong written and verbal communication skills.
• Strong decision making and problem-solving skills.
• Excellent planning and organizational skills with demonstrated multi-tasking and project management skills.
• Must be able to travel up to 25% of the time.
• Must have the ability to complete required applicable forms in English, which requires the ability to read and write in English.
• Ability to work well with others in fast paced, dynamic environment.
• Ability to be respectful, approachable and team oriented while building strong working relationships and a positive work environment.
  
  

Supervisory Responsibilities

• Provides leadership and guidance to employees in the Quality Control, Quality Assurance, and Regulatory Affairs departments
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and assisting in providing appropriate resolutions.
  
  

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

$155,000.00 - $232,625.00