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Manager, Manufacturing Quality Assurance

Company: Sagent Pharmaceuticals
Location: Raleigh
Posted on: August 8, 2022

Job Description:

Job Description Sagent Pharmaceuticals – Raleigh, NCManufacturing Quality Assurance Manager Sagent Pharmaceuticals, founded in 2006, was built to focus on customer needs. At Sagent, we believe that excellence is our standard, our motivation and our guide. We believe the measure of success is determined by our customers, as we are a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling the evolving needs of the patients we serve through our unique network of global resources. The Manufacturing Quality Assurance (MQA) Manager is responsible for leading and managing activities within the MQA group. The scope of responsibilities includes On The Floor oversight of Manufacturing and Packaging, Batch record review and approval, Disposition of raw materials, components, and products, Manufacturing deviations, Complaint investigations, Systems Release Program, and Sample Retain Program. The incumbent will work in close collaboration with Production, Logistics, Compliance Quality Assurance, and Quality Control personnel to develop, implement and manage quality assurance processes, procedures, and best practices. The MQA Manager supports audits/inspections and helps to maintain the site is a constant state of inspection readiness. Key Duties and Responsibilities:

  • Supervise, develop, manage, and train direct reports in Manufacturing Quality Assurance. Effectively hire, develop, counsel, manage, and motivate staff. Write and administer performance appraisals for department personnel. Update and procure approval of job descriptions for department personnel.
  • Maintain approved budget for direct reporting staff
  • Create, review, and approve documents, including SOPs and master batch records
  • Manage disposition of raw materials, components, and product
  • Manage the review and disposition of executed batch records
  • Review and approve deviations, include CAPAs associated with manufacturing operations
  • Review and approve non-conformances, CAPAs, and change controls related to the area of responsibility
  • Perform complaint investigations
  • Manage the Systems Release Program
  • Manage the Sample Retain Program
  • Develop, support, and sustain appropriate metrics including preparing trend data for presentation to management during weekly, monthly, and quarterly reviews
  • Participate and represent MQA during regulatory, customer, and internal audits
  • Provide support of stability programs for marketed products
  • Provide regulatory expertise to the technology transfer process, as needed
  • Assure job objectives are met on a timely basis and escalate Quality issues to the Quality Director and relevant Sagent Leadership Team Members
  • Proactively drive a culture of continuous improvement
  • Communicate effectively/efficiently with others in a professional manner
  • Manage a wide variety of tasks under critical time constraints Candidate Qualifications/Experience:
    • Bachelor's degree in a scientific (or related) field
    • 8+ years of experience with 5+ years of progressive supervisory experience in pharmaceutical manufacturing preferred
    • Prior Quality System experience – including ComplianceWire, TrackWise and VeevaVault
    • In depth knowledge and experience with USP, CFR, ICH, and ISO regulations and guidelines
    • Knowledge and understanding of regulatory requirements such as 21 CFR Part 210 and 211, cGMPs, and GDPs
    • Advance computer skills, knowledgeable of data analysis, and statistical methods
    • Successful implementation of continuous improvement opportunities Physical Requirements of the Role:Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesion that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products. Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.modification to reasonably accommodate individuals with a disability.

Keywords: Sagent Pharmaceuticals, Raleigh , Manager, Manufacturing Quality Assurance, Executive , Raleigh, North Carolina

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