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Operational QA Manager - 2nd Shift

Company: GlaxoSmithKline
Location: Rockville
Posted on: May 20, 2025

Job Description:

Site Name: USA - Maryland - Rockville Posted Date: May 16 2025 GSK is currently looking for an Operational Quality Manager to join our team in Rockville, MD. The OQ Manager will be responsible for operational quality activities at the LSM/SSM site, including batch record review and daily quality operations. They will manage a team of quality professionals responsible for batch record reviews, GMP operation confirmation, and supporting groups such as laboratory and engineering. The main liaison with production management and participation in daily planning meetings are key aspects of this role. Key Responsibilities:

  • Manage a team of operational quality professionals (24/7) supporting production and shop floor activities.
  • Ensure schedules and activities support batch record review and disposition; review and approve deviation reports, CAPAs, and GMP documentation.
  • Serve as QA representative at product team meetings, participate in facility design and drug development teams.
  • Support data integrity and human performance initiatives to reduce incidents and enhance employee engagement.
  • Understand and mitigate quality risks in production areas to support schedules.
  • Support performance improvement initiatives in the BDS release area to meet site service goals. Why you? Basic Qualifications:
    • BSc Degree
    • 5+ years GMP pharmaceutical experience
    • Availability to work Wed-Sat, 2:00 PM - 1:00 AM EST Preferred Qualifications:
      • Biopharm experience preferred
      • 2+ years supervisory experience preferred
      • Experience managing deviations and process changes
      • Knowledge of performance improvement tools (e.g., Six Sigma)
      • Understanding of GMP, ICH, and regulatory guidelines
      • Strong organizational, leadership, communication skills
      • Ability to handle multiple projects and work in a fast-paced environment
      • Technical expertise in process improvements and quality compliance #LI-GSK The annual base salary ranges from $96,525 to $160,875, depending on various factors. Benefits include health insurance, retirement plans, paid holidays, and more. Visit for details. Why GSK? GSK is a global biopharma company committed to uniting science, technology, and talent to improve health worldwide. We focus on vaccines, medicines, and innovative science in areas like infectious diseases, HIV, respiratory/immunology, and oncology. Our success depends on our people. We aim to create a workplace where everyone feels valued, inspired, and able to grow. Join us in our journey to get Ahead Together. If you need accommodation to apply, contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer, committed to diversity and inclusion. Note to employment agencies: GSK does not accept referrals without prior authorization. For more info on compliance and reporting, visit the CMS website at .
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Keywords: GlaxoSmithKline, Frederick , Operational QA Manager - 2nd Shift, Executive , Rockville, Maryland

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