External Quality Senior Lead Lab activities

Role Summary

External Quality Senior Lead Lab activities. Oversight and management of quality assurance for external laboratories, third-party service providers, and CMOs with emphasis on analytical testing, compliance, and regulatory inspection readiness. Collaborates with Central QC and internal stakeholders to align analytical oversight and quality standards.

Responsibilities

• Provide quality oversight in alignment with GLP and global regulatory requirements.
• Support method validation, verification, and performance analysis for analytical methods at CMOs and external laboratories.
• Ensure inspection readiness for regulatory audits and maintain audit-ready documentation and processes.
• Oversee compliance of methods and specifications at CMOs/TPs with regulatory details, Pharmacopeia standards, and GSK protocols.
• Provide QA oversight for investigations into OOS results, laboratory deviations, and non-conformance events.
• Assist with Local Incident Committee (LIC) and Product Incident Review Committee (PIRC) activities related to analytical issues.
• Ensure compliance with stability programs, nitrosamines testing, and regulatory guidelines.
• Lead quality agreement negotiations with CMOs/TPs and monitor adherence to agreements.
• Collaborate with cross-functional teams to align analytical activities with GSK‚Äôs overall quality strategy.
• Provide training and mentorship to internal teams and external partners on GSK analytical standards and quality expectations.

Qualifications

• Required: Bachelor‚Äôs degree in a science-related field with experience in quality operations/quality control.
• Required: 8+ years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a focus on laboratory operations and analytical oversight.
• Required: Experience with method validation, stability programs, and regulatory compliance.
• Required: Experience in managing analytical investigations (OOS, deviations) and supporting regulatory inspections.
• Required: Experience working with quality systems (change control) and quality control processes.
• Preferred: Experience with GMP, GLP, GXP, ICH guidelines, and quality systems implementation.
• Preferred: Demonstrated sense of urgency and broad knowledge of quality systems principles and risk management.
• Preferred: Technical knowledge of multiple dosage forms and strong statistical data analysis capabilities.
• Preferred: Strong project management, communication, negotiation, and cross-functional collaboration skills.
• Preferred: Intercultural skills and ability to work independently with external companies.

Skills

• Quality assurance and regulatory compliance
• Analytical method validation and verification
• OOS and deviation investigations
• Quality systems (change control, documentation)
• Audit readiness and regulatory inspections
• Cross-functional collaboration and stakeholder management
• Training and mentorship
• Statistical analysis and data trending