Full-Time

Senior Director

Quality, Bioscience

Posted on 2/26/2025

Smithfield Foods

Smithfield Foods

5,001-10,000 employees

No salary listed

Senior, Expert

Company Does Not Provide H1B Sponsorship

Cincinnati, OH, USA

Relocation Package Available

Category
Diagnostics & Laboratory Professionals
Medical, Clinical & Veterinary
Required Skills
Word/Pages/Docs
Data Analysis
Excel/Numbers/Sheets
Requirements
  • Bachelor’s degree from an accredited four-year college or university in Analytical Chemistry or related field and 12+ years of relevant experience in the pharmaceutical industry; or equivalent combination of education and experience, required.
  • 5+ years of demonstrated experience in team management/development.
  • Strong working knowledge of FDA regulations, including 21 CFR Parts 11, 210, and 211, ICH Q7 and related FDA Guidance documents.
  • Excellent communication, planning, problem-solving, analytical, and organizational skills.
  • Detail oriented; able to deal with multiple changing priorities and able to work with minimal supervision.
  • Proficiency in data analysis and reporting. Applied knowledge of Word and Excel required. Knowledge of Inventory and Manufacturing software; Spreadsheet and Word Processing software; and major enterprise ERP(s) is a plus.
  • Ability to uphold regulatory, company, and customer standards.
  • Skilled at quality principles, pharmaceutical manufacture and Quality Management Systems (QMS).
  • Must be able to travel as needed.
Responsibilities
  • Oversees the quality management system and reports regularly to Company management on the state of the Quality system.
  • Sets Quality unit directions and goals, providing overall Quality leadership that fosters a strong compliance culture and promotes compliance with relevant regulations.
  • Leads regulatory and customer inspections, prepares written responses to findings/observations, and develops effective action plans to address any identified issues.
  • Supervises the internal and external audit programs.
  • Manages the site’s supplier qualification program, including audits, preparation of audit reports, assessment of CAPAs, and verification of CAPA effectiveness.
  • Oversees deviation, complaint and laboratory OOS investigations as well as the implementation of effective CAPAs.
  • Manages the site’s validation program, including review and approval of equipment, process, cleaning and water system validation protocols and reports.
  • Creates procedures and work instructions that promote conformance to product specifications and regulatory requirements.
  • Establishes a collaborative relationship with leadership, operations, sales, marketing and other internal departments and outside service providers.
  • Manages the design and implementation of effective training programs for QC, QA RA and Operations personnel, including training on regulatory requirements and data integrity/Good Documentation Practice (GDP).
  • Prepares and maintains the company’s Drug Master Files (DMF).
  • Participates in the new project design team, including reviewing new products, product design and product packaging, and making recommendations regarding quality and compliance.
  • Acts as Project Coordinator and/or Project Leader as assigned for special projects.
  • Represents the Company in discussions with customers, suppliers, auditors, and regulatory agencies (FDA, EMA, etc.).
  • Achieve financial objectives by preparing and managing the Quality unit budgets and related reports.
  • Trains, coaches and counsels QC, QA, and RA Managers in the activities of their departments to improve quality and compliance and enhance safety.
  • Initiates and handles personnel actions such as hires, transfers, promotions, discipline and terminations.
  • Meets and exceeds FDA and industry standards, achieving best-in-class adherence in the areas of safety and product quality.
Desired Qualifications
  • Qualification as a Certified Quality Auditor (CQA) through the American Society for Quality (ASQ) is desirable.

Company Size

5,001-10,000

Company Stage

Acquired

Total Funding

$4.7B

Headquarters

Sioux Falls, South Dakota

Founded

1936

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Simplify's Take

What believers are saying

  • Smithfield's IPO raised $522M, providing capital for growth and expansion.
  • The company is enhancing corporate governance with new compensation and incentive plans.
  • Smithfield's focus on community partnerships strengthens its brand and local impact.

What critics are saying

  • African Swine Fever outbreaks could disrupt Smithfield's supply chain and increase costs.
  • Environmental lawsuits may lead to increased regulatory scrutiny and operational expenses.
  • Trade tensions with China could impact Smithfield's export opportunities and profitability.

What makes Smithfield Foods unique

  • Smithfield Foods is a leader in value-added packaged meats and fresh pork.
  • The company has a strong community focus, donating to educational and hunger programs.
  • Smithfield's long history and recent IPO position it uniquely in the market.

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Company News

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