OQ Team Lead (Quality Oversight)

Regulatory Toolkit; Zebulon (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

GSK in North Carolina is seeking a Quality Oversight Leader to head a small team ensuring GMP compliance across manufacturing and QA documentation. The role focuses on risk assessment, CAPA, investigations, and cross-functional collaboration to protect patient safety and product quality.

You will drive audits, CAPAs, and continuous improvement while maintaining ALCOA++ data integrity and GDP compliance. onsite, with strong emphasis on regulatory readiness and cross-functional engagement.

Qualifications

• Bachelor’s degree in science, pharmacy, engineering, or equivalent pharmaceutical industry experience.
• 6+ years of manufacturing experience from pharmaceutical industry, biologics manufacturing, distribution, supplier quality, or quality operations.
• Experience with quality systems such as deviations, CAPA, change control, and document control.
• Experience with data trending, statistical analysis, and root cause analysis tools.
• Experience across multiple dosage forms, packaging or device assembly activities.
• Proven experience and strong knowledge of the application of the principles of Quality Management Systems (QMS).
• Strong written and verbal communication skills for cross-functional collaboration and supplier engagement.

Responsibilities

• Lead and coach the Operational Quality team to deliver consistent oversight of the Quality Management System. Monitor quality performance using metrics and trends, escalate risk, and collaborate on corrective action plans.
• Oversee investigations of deviations, non-conformances and complaint-related issues and drive robust root cause analysis. Review and approve batch records, certificates and quality documentation to meet regulatory and good documentation standards.
• Support product introductions, transfers and changes, prepare for and support audits and inspections, and coach internal teams and external partners on inspection readiness.
• Provide oversight, support, and accurate scheduling of activities to the quality team responsible for quality oversight of all GMP areas ensuring all requirements have been met, and the defined schedule is followed.
• Maintain presence across areas of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations.
• Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects.
• Perform a spot-check of activities across defined GMP areas to ensure compliance with quality standards that include production, testing, QC, warehouse, facilities and utilities.
• Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts.
• Review GMP documentation and records ensuring Good Documentation Practice (GDP) is being maintained following ALCOA++ principles for data integrity, audit and traceability.
• Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated and support timely implementation of remedial actions.
• Track and trend quality oversight observations on collected data and facilitate mitigation actions and regularly update and maintain the quality oversight risk assessment.
• Participates in and supports site-based audits/inspections as SME for Quality Oversight.

Skills

Quality Oversight

Data Trending

Root Cause Analysis

Cross-functional Collaboration

Quality Documentation

Education

Bachelor’s degree in science/engineering/pharmacy

Tools

QMS software

GDP tracking 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

You will lead a small Operational Quality team that provides quality oversight across manufacturing. You will work closely with manufacturing, and supply chain colleagues to protect product quality and patient safety. We value clear decision-makers who simplify processes, coach others, and drive measurable improvement. This role offers visible impact, career growth and the chance to unite science, technology and talent to get ahead of disease together.

• Lead and coach the Operational Quality team to deliver consistentoversightof the Quality Management System. Monitor quality performance using metrics and trends, esc ...? Actually the original says: escalated risk, andcollaborateoncorrectiveaction plans.

• Oversee investigations of deviations, non-conformances and complaint-related issues and drive robust root cause analysis. Review and approve batch records,certificatesand quality documentation to meet regulatory and good documentation standards.

• Support product introductions, transfers and changes,prepare for and support audits and inspections,and coach internal teams and external partners on inspection readiness.

• Provide oversight, support,andaccuratescheduling of activities to the quality team responsible for quality oversight of all GMP areas ensuring all requirements have been met, and the defined schedule is followed.

• Maintain presence acrossareasof responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as theinitialimpact assessment for deviations.

• Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing fortimelyinterventions to prevent deviations and defects

• Perform a spot-check of activities across defined GMP areas to ensure compliance with quality standards thatincludeproduction, testing,QC,warehouse,facilitiesandutilities.

• Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts.

• Review GMP documentation and records ensuring Good Documentation Practice (GDP) is beingmaintainedfollowing ALCOA++ principles for data integrity,auditand traceability

• Check that facilities are beingmaintainedin a good state in line with local housekeeping standards and any deviation from the standards are escalated and supporttimelyimplementation of remedial actions

• Track and trend quality oversight observations on collected data andfacilitatemitigation actions and regularly update andmaintainthe quality oversight risk assessment

• Participates in and supports site-based audits/inspections as SME for Quality Oversight.

Basic Qualifications

• Bachelor’s degree in science, pharmacy, engineering, or a related discipline, or equivalent pharmaceutical industry experience.

• 6+ years of manufacturing experience from pharmaceutical industry, biologics manufacturing, distribution, supplier quality, or quality operations.

• Experience with quality systems such as deviations, CAPA, change control, and document control.

• Experience with data trending, statistical analysis, and root cause analysis tools.

• Experience across multiple dosage forms,packagingor device assembly activities.

• Proven experience and strong knowledge of the application of the principles of Quality Management Systems (QMS)

• Strong written and verbal communication skills for cross-functional collaboration and supplier engagement

Preferred Qualifications

• Leading or supervising a quality team in operations or supplier quality. Working knowledge of Good Manufacturing Practices and applicable U.S. regulatory expectations.

• Familiarity with inspection readiness and supporting regulatory inspection responses.

Work model

This role is an onsite position which requires you to be onsite. This is not a hybrid position.

What we value

We act with transparency, respect and integrity. We make evidence-based decisions and balance speed, rigor and risk. We welcome applicants from all backgrounds and support an environment of inclusion where everyone can do their best work.

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Technical Writing

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at [e-mail]

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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.