QC Chromatography Supervisor
Marietta, GA - USA
Job Summary
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; its 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 serve as the chromatography team leader and quality-system owner for the chromatography area partnering with Analytical SMEs Production Quality Control and Quality Assurance to resolve complex issues sustain inspection readiness and drive continuous improvement in laboratory performance and compliance. Own day-to-day QC chromatography laboratory operations to ensure release stability and non-routine analytical testing is executed reviewed and delivered to defined timelines in accordance with product registrations GMP standards and applicable regulatory expectations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
FRONT LINE LEADER RESPONSIBILITIES
Create and sustain a positive inclusive high-performance culture that strengthens cross-functional partnership (QC Production Technical Services QA Projects) reinforces shared ownership and aligns team behaviors to site and GSK objectives.
Provide day-to-day direction for the QC chromatography team by developing workload plans sequencing priorities allocating resources and escalating risks/issues to ensure safe compliant on-time delivery and right first time execution.
Maintain a strong laboratory presence (GEMBA) to coach execution remove barriers and confirm safety and laboratory upkeep quality compliance and output standards through disciplined GPS-based process confirmation.
Deliver full people leadership including onboarding training progression feedback performance management development/succession planning and proactive absence/holiday coverage planning to protect continuity of GMP testing and review.
COMPLIANCE
Own chromatography methods processes and associated GMP systems/documentation (e.g. HPLC/Empower SOPs analytical methods specifications sampling/testing requirements monographs and controlled documents) ensuring they remain current compliant inspection ready. Effectively delegate/coach senior team members to own these items. Participate in LES implementation for Business Cutover (BCO) and masterdata updates in SAP.
Ensure ALCOA data integrity and documentation excellence by setting expectations monitoring adherence and ensuring results/data are reviewed for compliance with procedures/specifications and escalation of questionable outcomes.
Lead chromatography change control and implementation ensure impacts are assessed documentation is prepared/approved training is deployed and practices remain aligned with compendia (USP/EP) and harmonized with other teams/sites as appropriate.
PROBLEM SOLVING
Lead the identification escalation and resolution of atypical/questionable results to protect product decisions and delivery timelines coordinating cross-functionally as needed.
Lead OOS/atypical results deviations and laboratory investigations to timely closure using structured root cause methodologies (e.g. DMAIC) ensuring robust CAPA definition implementation and effectiveness.
CONTINUOUS IMPROVEMENT
Drive continuous improvement and sustained inspection readiness by benchmarking best practices implementing compliant enhancements to methods/workflows/spaces/instruments through appropriate governance maintaining good housekeeping in lab and supporting audits/inspections (including internal audits) through effective SME engagement and closure of actions within agreed timelines. Utilize GPS tools for continuous improvement.
Responsibilities
Manage chromatography testing workflows (HPLC UHPLC GC as applicable) to meet quality and timeline commitments.
Maintain system suitability calibration records and instrument performance monitoring.
Approve analytical data trend results and related documentation in line with good documentation practices.
Participate in change control validation activities and method transfers related to chromatography methods.
Support internal and external audits by preparing documentation and serving as a subject-matter resource.
Promote a safe inclusive laboratory culture and ensure compliance with safety and GMP expectations.
Why You
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Bachelors degree in Chemistry Biochemistry Analytical Science or a related scientific field.
5 years demonstrated leadership in a laboratory of a high volume rapid turnaround testing.
5 years experience in a GMP/FDA regulated environment
5 years experience in Quality Control environment in a Chromatography laboratory
Preferred Qualification
If you have the following characteristics it would be a plus:
Knowledge of GMPs NIH Guidelines FDA and other regulatory agency requirements sufficient to apply to quality operations compliance and interfacing with regulatory auditors.
Sense of urgency flexibility and accountability in order to meet goals and deadlines.
Executive capability and leadership to manage people and field projects teams and embrace a team-based culture.
Strong skill in analysis and trending of laboratory data
Ability to work in a highly complex matrix environment with focus on attention to detail.
Intermediate to advanced computer skills required.
Proven record of providing excellent internal and external customer service.
Stay current on developments in the field and GSK-Bio Standards and demonstrate a serious commitment to accuracy and quality.
Maintain transparency and a high level of communication within (and outside) the team
Strong understanding of analytical methods overseen
Work Arrangement
Position may require employees to work in a rotational schedule. This schedule may include holidays and weekends; overtime may be required.
How to apply
If this opportunity resonates with you please submit your resume and a short note explaining your chromatography leadership experience and the impact you delivered. We welcome applicants from all backgrounds who value inclusion and practical teamwork. We look forward to hearing how you can help us deliver high quality results for patients.
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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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 were 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.
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About Company
About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.