Pharmaceutical QC Technical Services Manager

Overview

Full‑time Quality Control Lead reporting to the Senior Manager of Quality Control. Responsible for leading technical operations related to QC in a pharmaceutical environment, ensuring compliance with FDA cGMP,21

CFRPart
11,EUAnnex
11, andGAMP
5. Oversight of validation/verification, system administration, method optimization, and cross‑functional coordination.

• Qualification of testing equipment and validation of laboratory data systems.
• Software system administration, including data backup and ensuring 21
  
  CFRPart
  11 & EU Annex
  11 compliance.
• Validation/verification of QC methods and analytical method optimization, transfer and lifecycle improvement.
• Lead and assign technical tasks for commissioning, qualification, and validation of laboratory equipment and software.
• Provide cross‑functional leadership: training, coaching, mentoring, and performance counseling.
• Champion cGMPs, safety, and workplace activities; support QC OOS investigations and CAPA.
• Resolve equipment, software or testing issues with cross‑functional teams.
• Draft, revise and review technical protocols, reports, SOPs and worksheets following GDP.
• Oversee the software development lifecycle for validated systems and ensure metrics and records are maintained.
• Manage employee performance and support their success.

• Bachelor’s degree in chemistry, microbiology, or related technical field.
• 5+ years of FDA cGMP compliance experience in a QC laboratory.
• 2+ years of team management or project leadership experience.
• Strong leadership skills and ability to uphold regulatory, company and customer standards.
• Proficiency in complex mathematical calculations, scientific writing and communication skills.
• Ability to develop work plans, manage priorities, and work well in high‑pressure environments.
• Demonstrated ability to work with cross‑functional teams.

Salary range: $117,000 – $175,125. Relocation package available.

EEO Statement:
Smithfield is an equal‑opportunity employer and will provide reasonable accommodations for qualified applicants with disabilities.