External Quality Senior Lead Lab activities

The purpose of this role is to be responsible for overseeing and managing quality assurance activities related to external laboratories, third-party service providers, and contract manufacturing organizations (CMOs). This role has a particular emphasis on analytical testing, compliance, and preparation for regulatory inspections. The Senior Lead will work closely with GSK’s Central QC Team to ensure alignment in analytical oversight and quality standards, drive improvements, and ensure adherence to regulatory requirements and GSK protocols.

Additionally, this role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CMO/Third-Party. These include key contacts with (but are not limited to) Quality, QC, Regulatory, Business Development, Production, Site Management and others.

The External Quality Senior Lead must also develop and maintain an effective working relationship with internal stakeholders including Central QC Team, External Manufacturing and Procurement Managers, as well as contacts within Regulatory, Technical, Procurement, relevant internal GSK Sites and Local Operating Companies (LOC’s) Quality function.

Key Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Provide quality oversight in alignment with GSK expectations, Good Laboratory Practices (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 Out of Specification (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’s overall quality strategy.
• Provide training and mentorship to internal teams and external partners on GSK analytical standards and quality expectations.

Why You:
Basic Qualifications:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachlors degree in a science related field with experience in and quality operations/ quality control.
• 8+ years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a focus on laboratory operations and analytical oversight.
• Experience with method validation, stability programs, and regulatory compliance.
• Experience in managing analytical investigations (OOS, deviations) and supporting regulatory inspections.
• Experience working with quality systems (change control) and quality control processes

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

• Experience working with GMP, GLP, GXP, ICH guidelines, and quality systems implementation.
• Demonstrated sense of urgency.
• Breadth in quality systems principles and practical application.   
• Good knowledge and demonstrated application of quality and risk management principles and tools.
• Demonstrated decision-making capability; based on facts & data, and application of Risk Management principles.
• Technical knowledge of multiple dosage forms.
• Strong capability of statistical analysis of data trending
• Demonstrated ability to effectively multi-task.
• Strong Project Management skills and delivery.
• Excellent verbal and written communication skills; with strong presentation skills.
• Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders
• Strong problem solving skills.
• Demonstrated ability to work and collaborate in cross-functional teams.
• Demonstrated intercultural skills.
• Excellent written and spoken language skills; primary English and any secondary language is desirable.
• Demonstrated commercial acumen to effectively work with external companies
• Ability to adapt, anticipate issues, work under uncertainty and accommodate