Compliance and Systems Lead

Business Introduction
Part of the GSK global network of 37 manufacturing sites that produce high-quality medicines and vaccines GSK Marietta makes a positive impact on the health of millions of people every year.

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 seek the very best minds and capability to help us deliver world-class performance with our current business and shape best practices for our future business.

Recently awarded an $800m investment to build new drug substance and drug product manufacturing facilities on the campus there has never been a more exciting time to join the GSK Marietta site team.

Position Summary

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 highcapability 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 crossfunctional collaboration championing data integrity and sustaining inspection readiness the Compliance & Systems Lead shapes a proactive quality culture and enables rightfirsttime outcomes that support the sites longterm success.

People Leadership & Talent Pipeline

• Maintain oversight of team workload priorities and performance through KPI trending project management tools and clear prioritysetting to ensure timely compliant and highquality 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 datadriven decisionmaking; contribute to site talent management and strategic workforce planning.

Quality Systems Excellence

• 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 rootcause methodologies highquality 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 teamincluding Standard Operating Procedures (SOPs) validation documentation and training materialsleveraging 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 teams execution of management monitoring audittrail review practices and preparation for internal and external inspections.

Operations Digital System Ownership

• 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 fitforpurpose functionality; and by overseeing the quality and standardization of process maps workflow designs system lifecycle documentation and technical specifications developed by Systems Specialists.

Performance Management and Continuous Improvement

• 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 crossfunctional partners to ensure the team has the context alignment and collaboration pathways needed to deliver projects resolve issues support operational flow and maintain effective endtoend processes compliant with Quality and EHS requirements.

Why You

Basic Qualification
We are seeking leaders who enjoy improving systems and building teams with the following required skills and qualifications to help us achieve our goals:

• Bachelors 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 crossfunctional 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.

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

• Masters 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.

Work model
This role is primarily on-site for hands-on collaboration (4 days per week) with opportunity for remote days for focused work. GSK operates a Flexible Working Hours policy.

How to apply

If you want to lead at the intersection of Operations Quality and Digital Technologiesand build toward future site leadership positions apply now.

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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.

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