LOC Quality Manager

GSKNew York, NY
Onsite

About The Position

This role supports operational quality activities at the Philippines site, working with the Local Operating Country Quality Manager and cross-functional teams to maintain an effective and inspection-ready Quality Management System. The position involves managing day-to-day quality operations, supporting investigations, and driving improvements to ensure patient safety. The company values individuals who are practical, curious, collaborative, and committed to learning, offering visible impact, career growth, and the opportunity to unite science, technology, and talent.

Requirements

  • Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering or related scientific discipline; or equivalent professional qualification.
  • At least 3 to 5 years’ experience in quality assurance or operational quality in the life sciences or pharmaceutical sector.
  • Practical knowledge of Good Manufacturing Practices and Good Documentation Practices.
  • Experience with batch documentation review, in-process checks and product release support.
  • Experience managing deviations, CAPAs, investigations and quality records.
  • Proficient in MS Office and able to use standard business systems and email.
  • Good collaboration and communication skills.

Nice To Haves

  • Bachelor of Pharmacy, Pharm-D, or higher degree in a relevant field.
  • Experience with ERP or quality systems such as SAP or similar.
  • Experience leading self-inspections, internal audits or supporting regulatory inspections.
  • Knowledge of data integrity principles and practical application.
  • Experience working with third-party manufacturers, warehousing or distribution operations.
  • Comfortable working under pressure and able to manage multiple priorities.
  • Licensed Pharmacist

Responsibilities

  • Maintain and operate the local Quality Management System to meet GSK standards, good manufacturing practices and local regulations.
  • Review production and batch documentation and support timely lot release decisions.
  • Support investigations, root cause analysis and corrective actions for deviations, complaints and audit findings.
  • Perform self-inspections and support external audits and regulatory inspections.
  • Monitor quality performance metrics, perform trending and drive continuous improvement actions.
  • Coordinate quality activities with third-party providers, suppliers and cross-functional teams.
  • Ensure operations follow approved procedures and records are accurate and complete.
  • Coach production and warehouse teams on good documentation practices and GMP behaviours.
  • Manage quality records, retained samples and documentation to meet retention and data integrity expectations.
  • Support risk assessments and change control to ensure changes are appropriately managed.
  • Contribute to CAPA, deviation and complaint management to ensure timely, compliant closure.
  • Prepare for and support internal and external audits, inspections and corrective actions.
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