External Quality Senior Lead Lab activities

GSK; Ware; On-site; GBP 103,000 - 173,000; Full time

Job summary

A global biopharma company in Ware is seeking a Senior Lead for Quality Assurance. The role involves overseeing quality assurance activities related to external laboratories and CMOs, ensuring compliance with regulatory standards, and managing analytical oversight. Candidates should have over 8 years of experience in Quality Assurance within the pharmaceutical industry and a science-related degree. This position offers a competitive salary, annual bonus, and various benefits.

Benefits

Annual bonus

Health-care benefits

Retirement benefits

Paid holidays

Vacation

Qualifications

• 8+ years of experience in Quality Assurance within the pharmaceutical industry.
• Experience with method validation, stability programs, and regulatory compliance.
• Strong capability in managing analytical investigations and regulatory inspections.

Responsibilities

• Provide quality oversight in alignment with GSK expectations.
• Ensure inspection readiness for regulatory audits.
• Lead quality agreement negotiations with CMOs and monitor adherence.

Skills

Quality oversight

Analytical testing

Regulatory compliance

Project management

Statistical analysis

Decision making

Education

Bachelor's degree in a science related field

Tools

Quality systems

GMP

GLP

Job description

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.

Responsibilities

• 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.

Requirements

• Bachelor’s degree in a science related field with experience in 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

• 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 flexible work demands.
• Capable of working independently.

Compensation and Benefits

The US annual base salary for new hires in this position ranges from $136,125 to $226,875. In addition, this position offers an annual bonus and eligibility to participate in our share‑based long‑term incentive program which is dependent on the level of the role. Available benefits include health‑care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.