Compliance and Systems Lead
GSK
6 months ago
Remote friendly (Marietta, PA)
United States
Corporate Functions
Position Summary
- Lead compliance and systems across manufacturing, inspection and packaging teams to elevate operational performance.
- Develop and lead a high-capability Compliance and Systems team; ensure continuous improvement of quality, digital systems, and compliant ways of working.
- Strengthen investigation quality, drive meaningful insights into actions, and ensure health/effectiveness of critical processes and digital platforms.
- Foster cross-functional collaboration, champion data integrity, and sustain inspection readiness to enable right-first-time outcomes.
People Leadership & Talent Pipeline
- Maintain oversight of team workload, priorities, and performance using KPI trending, project management tools, and clear priority-setting.
- Coach and mentor Specialists in business process/system knowledge, project management, risk recognition, digital fluency, and data-driven decision-making; support talent management and workforce planning.
Quality Systems Excellence
- Partner with site quality system owners to adopt new QMS requirements, implement process changes effectively, and support network escalations.
- Oversee effectiveness of investigations, CAPA, and change control; guide specialists in impact assessment, robust investigation/root-cause methodologies, high-quality CAPA, and timely task progression to meet regulatory/QMS standards (lead most complex investigations as needed).
- Govern accuracy, currency, quality, and standardization of technical documentation (SOPs, validation documentation, training materials) to enhance usability, data integrity, and compliance.
- Lead risk governance and benchmark compliance expectations; oversee management monitoring, audit-trail review practices, and internal/external inspection preparation.
Operations Digital System Ownership
- Own critical Operations digital platforms (e.g., MES, SAP, OSI PI, electronic Batch Record): sustain system health, validation compliance, change management, and fit-for-purpose functionality.
- Oversee quality/standardization of process maps, workflow designs, lifecycle documentation, and technical specifications.
Performance Management and Continuous Improvement
- Evaluate operational insights from performance trends, deviations, complaints, risks, and QA oversight to identify patterns and proactively improve procedures, systems, equipment design, and ways of working.
- Engage cross-functional partners to ensure alignment for projects, issue resolution, operational flow, and end-to-end processes compliant with Quality and EHS requirements.
Why You?
Basic Qualifications (Required)
- Bachelor’s degree in a scientific, technical, engineering, or related field (STEM).
- 5+ years’ experience in regulated manufacturing (GMP) or life sciences environment.
- Experience managing others; influencing cross-functional teams; defining priorities; supporting regulatory inspections.
- Experience with electronic manufacturing systems (e.g., electronic batch records).
- Experience with problem solving, root cause analysis, change control, and writing technical documentation.
Preferred Qualifications
- Master’s degree (STEM).
- System validation and configuration for GMP-regulated systems.
- Data integrity principles and regulatory inspection readiness.
- Project management experience (on time/on budget).
- Continuous improvement methods (Lean/Six Sigma/GPS Orange Belt).
- Mentoring/coaching and capability building.
- Practical understanding of manufacturing operations and technical transfer activities.
- Strong written/verbal communication; experience creating SOPs/technical documentation.
- Ability to lead cross-functional tasks 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.
Work Model
- Primarily on-site for hands-on collaboration (4 days/week); opportunity for remote days; Flexible Working Hours policy.
How To Apply
- Apply now if you want to lead at the intersection of Operations, Quality, and Digital Technologies, and build toward future site leadership positions.
- Lead compliance and systems across manufacturing, inspection and packaging teams to elevate operational performance.
- Develop and lead a high-capability Compliance and Systems team; ensure continuous improvement of quality, digital systems, and compliant ways of working.
- Strengthen investigation quality, drive meaningful insights into actions, and ensure health/effectiveness of critical processes and digital platforms.
- Foster cross-functional collaboration, champion data integrity, and sustain inspection readiness to enable right-first-time outcomes.
People Leadership & Talent Pipeline
- Maintain oversight of team workload, priorities, and performance using KPI trending, project management tools, and clear priority-setting.
- Coach and mentor Specialists in business process/system knowledge, project management, risk recognition, digital fluency, and data-driven decision-making; support talent management and workforce planning.
Quality Systems Excellence
- Partner with site quality system owners to adopt new QMS requirements, implement process changes effectively, and support network escalations.
- Oversee effectiveness of investigations, CAPA, and change control; guide specialists in impact assessment, robust investigation/root-cause methodologies, high-quality CAPA, and timely task progression to meet regulatory/QMS standards (lead most complex investigations as needed).
- Govern accuracy, currency, quality, and standardization of technical documentation (SOPs, validation documentation, training materials) to enhance usability, data integrity, and compliance.
- Lead risk governance and benchmark compliance expectations; oversee management monitoring, audit-trail review practices, and internal/external inspection preparation.
Operations Digital System Ownership
- Own critical Operations digital platforms (e.g., MES, SAP, OSI PI, electronic Batch Record): sustain system health, validation compliance, change management, and fit-for-purpose functionality.
- Oversee quality/standardization of process maps, workflow designs, lifecycle documentation, and technical specifications.
Performance Management and Continuous Improvement
- Evaluate operational insights from performance trends, deviations, complaints, risks, and QA oversight to identify patterns and proactively improve procedures, systems, equipment design, and ways of working.
- Engage cross-functional partners to ensure alignment for projects, issue resolution, operational flow, and end-to-end processes compliant with Quality and EHS requirements.
Why You?
Basic Qualifications (Required)
- Bachelor’s degree in a scientific, technical, engineering, or related field (STEM).
- 5+ years’ experience in regulated manufacturing (GMP) or life sciences environment.
- Experience managing others; influencing cross-functional teams; defining priorities; supporting regulatory inspections.
- Experience with electronic manufacturing systems (e.g., electronic batch records).
- Experience with problem solving, root cause analysis, change control, and writing technical documentation.
Preferred Qualifications
- Master’s degree (STEM).
- System validation and configuration for GMP-regulated systems.
- Data integrity principles and regulatory inspection readiness.
- Project management experience (on time/on budget).
- Continuous improvement methods (Lean/Six Sigma/GPS Orange Belt).
- Mentoring/coaching and capability building.
- Practical understanding of manufacturing operations and technical transfer activities.
- Strong written/verbal communication; experience creating SOPs/technical documentation.
- Ability to lead cross-functional tasks 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.
Work Model
- Primarily on-site for hands-on collaboration (4 days/week); opportunity for remote days; Flexible Working Hours policy.
How To Apply
- Apply now if you want to lead at the intersection of Operations, Quality, and Digital Technologies, and build toward future site leadership positions.