Quality Control Director

GlaxoSmithKline; United States; Hybrid; USD 150,000 - 190,000; Full time

Job summary

GlaxoSmithKline seeks a Quality Control Director to lead laboratory operations across analytical, biochemical, and microbiological testing, ensuring compliance with GMP and readiness for inspections. You will align QC activities with site manufacturing and new product introductions, delivering high-quality data and supporting site objectives.

This role partners with Manufacturing, QA, Engineering, and Validation to drive readiness, transfer methods, and lifecycle changes; and oversees staffing,

Qualifications

• Bachelor's degree in a scientific field or related discipline.
• 8+ years supervisory/managerial experience in a GMP environment.
• Experience in Quality Control laboratory operations.
• Experience supporting regulatory inspections and audits.
• Working knowledge of quality systems and regulatory expectations.
• Ability to lead teams and work cross-functionally to manage priorities and deliver results.

Responsibilities

• Lead and oversee Quality Control laboratory operations supporting GMP testing, release, and stability programs.
• Ensure laboratories are inspection-ready and operate in compliance with regulatory and quality system requirements.
• Provide leadership for QC readiness activities related to new product introductions, technology transfers, and lifecycle changes.
• Oversee method transfer and assay qualification activities in alignment with technical and regulatory requirements.
• Ensure effective QC organizational readiness, including staffing, training, onboarding, and capability development.
• Support QC involvement in commissioning, qualification, and validation activities for laboratory facilities, equipment, and systems.
• Ensure laboratory data integrity, documentation accuracy, and adherence to ALCOA principles.
• Partner with Manufacturing, QA, Engineering, Validation, and Development to support site priorities.
• Support internal and external audits and regulatory inspections.
• Contribute to continuous improvement initiatives and operational excellence within the QC organization.

Skills

GMP knowledge

Quality control

Leadership

Cross-functional collaboration

Regulatory inspections

Education

Bachelor's degree in a scientific discipline

Master's or PhD preferred

Tools

Digital lab systems

Automation

Data reporting tools

Job description

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.

Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

The Quality Control Director is responsible for leading Quality Control laboratory operations to ensure they are organizationally, technically, and operationally prepared to support commercial manufacturing and new product introductions across the validation lifecycle.

This role provides scientific and operational leadership across analytical, biochemical, and microbiological laboratories supporting raw material testing, in-process and finished product testing, and stability programs. The position partners cross-functionally to ensure inspection readiness, regulatory compliance, and reliable delivery of high-quality laboratory data that supports site objectives and regulatory commitments.

Responsibilities

• Lead and oversee Quality Control laboratory operations supporting GMP testing, release, and stability programs.
• Ensure laboratories are inspection-ready and operate in compliance with regulatory and quality system requirements.
• Provide leadership for QC readiness activities related to new product introductions, technology transfers, and lifecycle changes.
• Oversee method transfer and assay qualification activities in alignment with technical and regulatory requirements.
• Ensure effective QC organizational readiness, including staffing, training, onboarding, and capability development.
• Support QC involvement in commissioning, qualification, and validation activities for laboratory facilities, equipment, and systems.
• Ensure laboratory data integrity, documentation accuracy, and adherence to ALCOA principles.
• Partner with Manufacturing, QA, Engineering, Validation, and Development to support site priorities.
• Support internal and external audits and regulatory inspections.
• Contribute to continuous improvement initiatives and operational excellence within the QC organization.

Basic Qualification

• Bachelor's degree in a scientific or technical discipline (e.g., Chemistry, Biochemistry, Microbiology, or related field).
• Minimum of 8 years of supervisory/managerial experience within a regulated GMP environment.
• Demonstrated experience in Quality Control laboratory operations.
• Experience supporting regulatory inspections and audits.
• Working knowledge of quality systems and regulatory expectations.
• Demonstrated ability to lead teams and work cross-functionally to manage priorities and deliver results.

Preferred Qualification

• Master's degree or PhD in a scientific discipline.
• Experience supporting new product introductions, method transfers, or technology implementations.
• Experience with digital laboratory systems, automation, or data/reporting tools.

Work Arrangement

This role is on-site or hybrid, depending on site requirements. Remote-only working is not available.

Benefits

GSK offers a comprehensive benefits program for U.S. employees.

Equal Opportunity Employment

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.