Site Quality Head

7/8/21

Shreeveport, LA 19342

1295

FullTimeRegular

Reporting to the Head of Quality & Regulatory the Site Quality Head is in charge of Quality Assurance, Quality Control and Quality Compliance, ensuring compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation

The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality control, attention to detail, and excellent communication with other functional areas and sites.

Responsibilities

Overall responsibility for quality operations and initiatives, including:
  • Quality Assurance, Quality Control, and Quality Compliance management.
    • In collaboration with the Quality Assurance team, responsible for:
      • Documentation control (master batch record, specification & method)
      • Batch record review and product disposition
      • Investigations, complaints, deviations, CAPAs, APRs
      • Production and Pharmaceutical Development support
      • APRs, GMP training and SOP review
      • Validation /qualification documentation review & approval
      • QA Operations – inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site
      • Develop, maintain, and enhance training programs and systems at DRL Shreveport site
    • Quality Compliance management:
      • In collaboration with the Quality and Compliance team from North America Region
        • All audits, internal, external – regulatory, client and vendor
        • Vendor management program
        • QA Agreements with clients & contractors
        • License renewals
      • Quality Control Management
        • Approve or reject starting materials, packaging materials, labeling and intermediate, bulk and finished products in relation to their specifications
        • Evaluate completed formulation records and other relevant information to ensure procedures were followed, product tests performed appropriately and acceptance criteria met
        • Review sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for intended use
        • Approve and monitor analyses carried out under contract through private labs
        • Lead the activities associated with monitoring the maintenance of the department(s), premises, processes, and equipment
        • Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are carried out
      • Budget
        • Plan and monitor the Quality Assurance department’s annual budget and develop any action plans necessary to ensure achievement.
      • Leadership
        • Manage, develop and motivate the Quality Team:
          • Make decisions pertaining to the workforce according to the company’s current policies and guidelines.
          • Implement an efficient organizational structure.
          • Support continuous improvement and/or cost reduction projects
        • Determine the professional development needs among the managers and the quality group and elaborate action plans in collaboration with the Human Resources Department.
        • Develop and Maintain Key Performance Indicators for the Quality Operation and discuss performance/opportunities
        • Coach employee & share expertise in quality aspect, decision making and problem solving.
        • Ensure a strong relationship with DRL’s customers
        • Develop a client biased attitude in the Quality organization
        • Other duties as assigned

EDUCATION:

Bachelor of Science (B. S.), Masters preferred, related to the pharmaceutical industry

EXPERIENCE:

  • 15 years of experience in a pharmaceutical environment, in Quality Operations, with FDA Audit experience
  • Extensive knowledge of US and EU current Good Manufacturing Practices
  • Expertise in Quality Control Laboratory Operations
  • Microbiological services experience either through direct or line management
  • Experience with a CMO would be preferable
  • Excellent knowledge of validation requirements
  • Knowledge and experience with the Pharmacy code of Regulations, Board of Pharmacies, and US FDA cGMPs
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