Operational QA Manager

Company: GlaxoSmithKline
Location: Rockville
Posted on: September 18, 2024

Job Description:

Site Name: USA - Maryland - RockvillePosted Date: Aug 14 2024GSK is currently looking for an Operational Quality Manager to join our team in Rockville, MD. The OQ Manager will be responsible for Operational Quality's day-to-day activities at the LSM/SSM site, including batch record review and day-to-day Quality Operations. The OQ Manager will manage a team of Quality professionals accountable for batch record reviews and confirmation of GMP operations in production and support groups, i.e., laboratory and engineering. The job holder will be the main liaison with the production management team and will participate in daily planning meetings, approve deviations to processes, and support LSM/SSM activities.Key Responsibilities:

• Manage a team of Operational Quality professionals (24/7) to support production activities and shop floor presence.
• Ensure Operational Quality schedules and activities support batch record review and batch disposition needs. Review and approve deviation reports and corrective actions to support GMP decisions and material disposition.
• Review and approve SOPs, batch records, forms, and all other GMP documentation to support day-to-day operations.
• With the Operational Quality Associate Director, serve as QA representative at product team meetings (PTM, CMC, POMM), and participate in facility design teams and specific drug product development teams.
• Support Data Integrity and Human Performance efforts to reduce incidents and increase engagement with employees.
• Ensure that Quality risks in production areas are understood and appropriately mitigated to support production schedules.
• Actively support performance initiatives to achieve site service goals in the BDS release area.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
  • BS Degree
  • 5+ years in a GMP pharmaceutical environment
  • 2+ years of Quality Assurance or Operational Quality experience
  • Supervisory or management experience.Preferred Qualifications:If you have the following characteristics, it would be a plus:
    • Biopharm experience preferred
    • 2+ years supervisory experience strongly preferred
    • Experience managing deviations and changes to processes as author, reviewer, or approver
    • Knowledge in Performance Improvement tools, i.e., Six Sigma or equivalent
    • Ability to interpret and apply GMP, ICH, and other regulatory guidelines.
    • Excellent organization skills.
    • Effective oral and written communication skills.
    • Sound leadership skills and the ability to work effectively in a cross-functional team environment.
    • Ability to handle multiple projects and interface with individuals from various departments.
    • Ability to work in a fast-paced environment in a results-oriented fashion.
    • Technical expertise in process improvements and Quality Compliance requirements for the role.
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Keywords: GlaxoSmithKline, Potomac , Operational QA Manager, Executive , Rockville, Maryland