QC Immunology Supervisor

GSK

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profile Job Location:

Marietta, GA - USA

profile Monthly Salary: Not Disclosed
Posted on: 3 days ago
Vacancies: 1 Vacancy

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 lead provide leadership to immunology/colorimetry team. Ensure that all samples are tested and reviewed as per predefined timelines. Sample types include Utilities Finished Product Raw Materials Retention Samples and Validation Samples. Drive projects to closure in support of site goals. Serve as owner for Immunology/colorimetry Quality System Events. Ensure lab processes/tests are safely executed and are compliant with GMP/regulatory requirements. Escalate issues and successes of Immunology Team.

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 Immunology 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 immunology/colorimetry methods processes and associated GMP systems/documentation (e.g. Plate Reader Western Blot etc. 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 master data 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 immunology/colorimetry 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.


Why You

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

  • Bachelors degree in biology Immunology Biochemistry or a related scientific field.
  • 5 years experience 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 an Immunology or bioassay laboratory


Preferred Qualification
If you have the following characteristics it would be a plus:

  • Masters degree in Immunology Molecular Biology or a related field.
  • Knowledge of GMPs NIH Guidelines FDA and other regulatory agency requirements sufficient to apply to quality operations compliance and interfacing with auditors.
  • Serve as an SME (subject matter expert) in technical areas in order to provide information to others.
  • Ability to interface with regulatory auditors.
  • Understand when a topic must be escalated and carry out escalation.
  • Sense of urgency flexibility and accountability.
  • Executive capability and leadership to manage people and field projects teams.
  • Ability to communicate at all levels.
  • Willing to travel abroad.
  • Ability to work in a high complex matrix environment.
  • Must be a committed team player prepared to work in and embrace a team-based culture.
  • Ability to follow written procedures and document results in a neat and precise manner.
  • Intermediate computer skills required.
  • Proven record of providing excellent internal and external customer service.
  • Stay current on developments in the field and GSK-Bio Standards.
  • Work within a Multi-skilled team.
  • Maintain attention to detail while completing multiple or repetitive tasks.
  • Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
  • Maintain a high level of integrity while balancing multiple priorities and responsibilities.


Work arrangement
Position may require employees to work in a rotational schedule. This schedule may include holidays and weekends; over-time may be required.

How to apply
If this role speaks to you please submit your resume and a short note about your immunology leadership experience and the outcome you delivered. We welcome applicants from all backgrounds who value inclusion and practical teamwork. We look forward to learning how you can help us deliver high quality results for patients.

#LI-GSK

#GSKMarietta

#MariettaGSC

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.

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 -

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:

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Business IntroductionWe 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 posi...
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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.

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