Compliance and Systems Lead

Posted 3 Days Ago
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Marietta, PA, USA
In-Office
80K-120K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead compliance and systems in manufacturing to improve operational performance by developing staff, ensuring quality, digital systems, and compliant practices.
Summary Generated by Built In

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; it’s 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 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.

People Leadership & Talent Pipeline

  • 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.

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 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.

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 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.

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 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.

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:

  • 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.

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

  • 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.

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 Technologies—and build toward future site leadership positions —apply now.

#LI-GSK

#MariettaGSC

#GSKMarietta

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 we’re 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [email protected]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Top Skills

Electronic Batch Records
Mes
SAP
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The Company
HQ: Brentford
105,615 Employees
Year Founded: 2000

What We Do

A science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.

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