Compliance and Systems Lead

GSK•Marietta, PA

1d•Hybrid

About The Position

Working directly for the Site Value Stream Lead, you will lead compliance and systems across manufacturing, inspection and packaging teams to elevate operational performance by developing a high‑capability team of Compliance and Systems Specialists and ensuring that quality, digital systems, and compliant ways of working continuously improve. The role strengthens investigation quality, drives meaningful insights into actions, and ensures the health and effectiveness of critical processes and digital platforms that underpin Operations. By fostering strong cross‑functional collaboration, championing data integrity, and sustaining inspection readiness, the Compliance & Systems Lead shapes a proactive quality culture and enables right‑first‑time outcomes that support the site’s long‑term success.

Requirements

Bachelor’s degree in a scientific, technical, engineering or related field. (STEM)
5+ years’ experience in a regulated manufacturing (GMP) or life sciences environment.
Experience managing others, influencing cross‑functional teams, defining priorities, and supporting regulatory inspections.
Experience with electronic manufacturing systems, such as electronic batch records
Experience in problem solving, root cause analysis, change control, and writing technical documentation.

Nice To Haves

Master's degree in a scientific, technical, engineering or related field. (STEM)
Experience with system validation and configuration for GMP-regulated systems.
Familiarity with data integrity principles and regulatory inspection readiness.
Project management experience, including delivering projects on time and within budget.
Knowledge of continuous improvement methods such as Lean or Six Sigma or GPS Orange Belt.
Experience mentoring or coaching team members and supporting capability building.
Practical understanding of manufacturing operations and technical transfer activities.
Strong written and verbal communication skills with experience creating SOPs and technical documentation.
Demonstrated ability to lead cross-functional tasks and collaborate with quality, operations and IT partners.
Strong knowledge of QMS, EHS, and regulatory expectations.
Ability to read/approve validation documents, system specifications, and technical requirements.

Responsibilities

Maintain oversight of team workload, priorities, and performance through KPI trending, project management tools, and clear priority‑setting to ensure timely, compliant, and high‑quality task execution.
Develop the capabilities and future readiness of the Compliance and Systems team by coaching and mentoring Specialists in business process and systems knowledge, project management, risk recognition, digital fluency, and data‑driven decision-making; contribute to site talent management and strategic workforce planning.
Partner with site quality system owners to ensure adoption of new QMS requirements, effective implementation of process changes, and timely support for network escalations.
Oversee the effectiveness of investigations, CAPA, and change control activities, guiding Specialists on accurate impact assessment, robust investigation and root‑cause methodologies, high‑quality CAPA, and timely progression of tasks to ensure outputs meet regulatory and Quality Management System (QMS) standards. Leads the most complex investigations for the site when necessary.
Govern the accuracy, currency, quality and standardization of technical documentation owned by the team—including Standard Operating Procedures (SOPs), validation documentation, and training materials—leveraging appropriate technologies to enhance usability, data integrity and compliance.
Uphold inspection readiness and a strong quality culture by leading risk governance and setting benchmark compliance expectations, oversee the team’s execution of management monitoring, audit‑trail review practices, and preparation for internal and external inspections.
Lead system ownership of digital platforms critical to Operations (e.g., MES, SAP, OSI PI, electronic Batch Record) by ensuring the team sustains system health, site expertise, validation compliance, effective change management and fit‑for-purpose functionality; and by overseeing the quality and standardization of process maps, workflow designs, system lifecycle documentation, and technical specifications developed by Systems Specialists.
Direct the evaluation of operational insights from performance trends, deviations, complaints, risks, and Quality Assurance (QA) oversight to ensure the team identifies patterns and proactively improves procedures, systems, equipment design, and ways of working, for superior balanced scorecard results.
Engage with cross‑functional partners to ensure the team has the context, alignment and collaboration pathways needed to deliver projects, resolve issues, support operational flow, and maintain effective end-to-end processes compliant with Quality and EHS requirements.