QC Chromatography Supervisor

GSK•Marietta, PA

About The Position

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.

Requirements

Bachelor’s 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

Nice To Haves

Knowledge of GMP’s, 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

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.