QC Immunology Supervisor

GSK•Marietta, PA

2d•Onsite

About The Position

You will lead p rovide 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.

Requirements

Bachelor’s 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

Nice To Haves

Master’s degree in Immunology, Molecular Biology, or a related field.
Knowledge of GMP’s, 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.

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.
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.
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.
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.