GSK · 1 day ago
Quality Lead
United States
Full-time
Remote
Senior Level
5+ years expGSK is a global biopharma company that manufactures and supplies high-quality medicines and vaccines. As a Quality Lead, you will oversee the quality of assigned Contract Manufacturing Organizations to ensure product quality and compliance with regulatory standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead Quality Agreement negotiations with CMOs and implement Quality Systems performance management with appropriate KPIs based on contractual parameters
Ensure compliance with quality systems, Good Manufacturing Practices (GMP), and regulatory compliance for current products, new product introductions and transfers to External Suppliers
Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, coaching and identification of specific inspectional risks
Lead Quality Agreement negotiations with CMOs and implement Quality Systems performance management with appropriate KPIs based on contractual parameters
Monitor the quality performance of the CMO driving remedial action where necessary. Monitor and assess CMO’s key performance indicators, such as complaints and deviations as a mechanism to propose continuous improvement initiatives
Partner with GSK functions, such as Procurement, Quality, Technical and Supply to assure that potential quality and compliance issues are identified, communicated and promptly resolved in order to assure a secure source of supply of quality product
Partner with the CMO(s) to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality and regulatory compliance. Provide specific GMP training for contractors, where deemed necessary. Review and disposition batch records as needed
Drive periodic review of Quality Systems at the CMO(s), to complement audit processes. Where required, support the CMO by conducting GEMBAs and root cause analysis reviews for investigation of issues and development of remedial actions
Review and respond to CMO(s) regulatory inspections on matters that involve activities related to GSK products. Assess impact of inspections and CMO responses to Regulatory observations prior to submission to the associated agency
Work with External Suppliers to establish effective CAPAs, in response to GSK audit observations and ensure the CMO(s) manage these to acceptable closure
Support technical assessment and perform Quality assessment for new product introductions. Review and approve significant documentation associated with the introduction or transfer of a new or existing product to CMO(s), including regulatory documents. Provide quality requirements for technical transfer projects, validation exercises, laboratory methods, stability protocols, SOPs, internals specifications, master batch records and others as needed
Qualification
Required
Bachelor's degree in a Science or Engineering discipline and 5+ years' experience (Manufacturing, QC, Engineering, Validation or Quality Operations)
or Master's degree with 3+ years' experience
Experience with quality systems, including documentation and compliance
5+ years' experience in various Technical, Regulatory or Quality Assurance roles with at least 2+ years of combination product and device and packaging experience
Developing knowledge of regulatory requirements including biological products and facility licensing requirements
Preferred
Developing understanding of quality systems and quality control processes
Developing knowledge of GMP's, FDA, EU, ISO13485 and other regulatory agency requirements with an ability to apply to quality and compliance
Developing knowledge of combination product and device regulations
Developing knowledge of quality system principles and practical applications
Developing knowledge and ability to apply quality and risk management principles and tools
Demonstrated problem solving skills
Demonstrated ability to make grade level decisions based on facts and data and application of risk management principles
Experience with work related travel
Excellent written and oral communication skills -English; Developing presentation skills
Developing influencing and negotiating skills
Capable of working independently and as a member of cross functional teams
Benefits
Comprehensive benefits program GSK offers US employees
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
2026-01-16
2026-01-13
South China Morning Post
2026-01-08
Company data provided by crunchbase