External Quality Lab Director – GSK
At GSK, we manufacture and supply reliable, high‑quality medicines and vaccines to meet patients’ needs and drive our performance. The External Quality Lab Director leads the quality and compliance of laboratory services provided by external partners, ensuring compliant and efficient service for all external third parties based in their remit.
Responsibilities
* Management and development of an empowered team with necessary skills to support the current and future business.
* Ensuring Quality Oversight provided by the team is fully aligned with GSK expectations (Quality, Compliance, Supply), Good Laboratory Practices and global regulatory requirements – specifically on these activities:
o Method Validation and Verification
o Method performance Analysis
o Analytical Inspection Readiness Oversight – Review Inspection Readiness plans and support implementation and assessment activities. Monitor mitigation of inspectional risks and elevate as necessary
o CMO/TP methods and Specifications Compliance
o Analytical batch release and CoA generation when required.
o CMO/TP Investigations – Resolution, mitigation or rapid escalation of issues impacting product Quality, safety and efficacy.
o LIC/PIRC support for analytical topics
o CMO/TP Stability program oversight
o Nitrosamines testing oversight
* Development and delivery of a quality strategy for the assigned network in close collaboration with Central QC Team.
* Evaluate and qualify external laboratories and third‑party service providers through rigorous audits and assessments.
Basic Qualifications
* Bachelor's degree with 10+ years of experience in laboratory operations, quality assurance, or analytical testing within the pharmaceutical or biopharmaceutical industry
* Experience within quality systems (QA) and quality control processes
* Experience with analytical methods, validation processes, and laboratory management systems
* Experience within GLP and GMP environments
* Experience working with regulatory requirements
Preferred Qualifications
* Post graduate degree (MS or PhD)
* Good understanding of GXP’s and data integrity principles.
* Capable of managing across boundaries
* Excellent influencing and negotiating skills
* Excellent verbal and written skills – English
* Strategic thinking and decision‑making capabilities
* Proven ability to manage teams
* Demonstrated ability to develop and coach staff
This role offers a hybrid working model, providing flexibility to balance remote and on‑site work.
The US annual base salary for new hires in this position ranges from $163,350 to $272,250. This position also offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program.
Benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Locations: USA, UK – multiple sites across the United States and United Kingdom.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
* Industries: Pharmaceutical Manufacturing
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