Deviation Local Process Owner

GSK; EE. UU.; Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

GSK at the Marietta site is seeking a Deviation Local Process Owner to oversee deviation and CAPA systems in vaccine manufacturing. The role ensures adherence to Quality Systems procedures, drives KPI development, trend analysis, and corrective actions, and maintains inspection readiness across the site.

You will collaborate with quality, manufacturing, regulatory, and cross-functional teams to resolve quality issues, lead investigations, and implement robust preventive actions, aiming to

Formación

• Bachelor's degree in an engineering, pharmacy, biology, chemistry, chemical engineering or life sciences discipline.
• 5–8+ years of pharmaceutical or regulated industry quality experience with ownership of quality systems.
• Proven experience leading complex deviation investigations, CAPAs and system-wide improvements.

Responsabilidades

• Act as site-level SME for deviation and CAPA systems; manage KPI development, trend analysis, escalation and action plans.
• Lead inspection readiness activities; prepare data packages; interact with inspectors; author responses.
• Deliver training activities on deviation and CAPA systems; mentor users; perform root cause analysis and guide AI investigator training.
• Ensure compliance with current GMPs and regulatory requirements; maintain inspection readiness and certify quality system actions.
• Collaborate with cross-functional teams to review, investigate and resolve deviations; monitor trends and share learnings; coordinate with regulatory and audit teams.

Conocimientos

Deviation management

CAPA

Quality systems

Root cause analysis

Inspection readiness

Cross-functional collaboration

Regulatory inspections

Risk-based thinking

Educación

Bachelor's degree in Engineering, Pharmacy, Biology, Chemistry, Chemical Engineering, or Life Sciences

Descripción del empleo

Business Introduction:

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Technology is transforming how we manufacture vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary:

The Deviation Local Process Owner is the local owner of, and subject matter expert of, the deviation and CAPA systems and processes at the Marietta site. The purpose of the role is to ensure adherence standards and procedures through oversight of deviation and CAPA processes in support vaccine manufacturing at the Marietta site. Responsible for deviation and CAPA systems oversight, governance, site competency, and continuous improvement of the systems to ensure effectiveness in resolving/preventing /identifying quality issues through robust investigations and meaningful corrective actions. This role is also responsible for inspection readiness of the deviation and CAPA systems and processes. You will own and lead the management of deviation processes across local sites in the United States. In this pivotal role, you will collaborate closely with quality, manufacturing, supply chain, and regulatory teams to ensure deviations are handled efficiently and effectively. We value clear communicators who bring structure, problem-solving skills, and a passion for continuous improvement. Joining us means growing your career, making a real impact on quality operations, and helping unite science, technology, and talent to get ahead of disease together.

Key Responsibilities:

• Act as site-level system owner and SME for assigned deviation and CAPA systems, ensuring the Quality Systems procedures and processes are compliant with requirements. Own local deviation and CAPA system performance, including KPI development, trend analysis, escalation, and action plans. Lead inspection readiness activities, including system defense, data package preparation, inspector interaction, and response authorship.
• undefined. Responsible for delivering training activities on deviation and CAPA systems and procedures (Qualified Trainer).
• undefined. Mentor and coach site system users, providing technical guidance, system knowledge, and root cause analysis and A.I. investigator instruction. Proactively engage operations to positively impact system metrics/KPIs and investigation results. Lead system continuous improvement and simplification initiatives with measurable compliance and/or efficiency outcomes.
• Complete all activities in compliance with current GMPs, applicable regulatory requirements, and procedures, minimizing risk of non-compliance and maintaining inspection readiness at all times. Adhere to all GSK safety guidelines and procedures. Certify as a root cause analysis champion. Own and lead quality owned quality system actions like deviations, procedural revisions, CAPA tasks. Lead the local deviation process as the main point of accountability, ensuring timely and compliant management of deviations.
• Collaborate with cross-functional teams to review, investigate, and resolve deviations with strong root cause analysis and corrective actions. Monitor deviation trends and performance metrics to identify improvement opportunities and share learnings. Partner with regional and global quality teams to align deviation management practices and support system harmonization. Support training and coaching of employees on deviation procedures to build awareness and improve compliance. Coordinate with regulatory and audit teams to prepare for inspections related to deviations and support any required follow-up actions.

Basic Qualifications:

• Bachelor's degree required in Engineering, Pharmacy, Biology, Chemistry, Chemical Engineering, or Life Sciences discipline. Degree in another discipline acceptable will be considered with sufficient experience but you must have minimally a bachelor's degree.
• 5 to 8 + years of pharmaceutical or regulated industry experience within a Quality organization, with demonstrated ownership of quality systems. Proven experience leading complex deviation investigations, CAPAs, and system-wide improvements. Demonstrated ability to act independently as a quality decisionmaker, applying risk-based thinking in alignment with cGMP and regulatory expectations.
• Experience supporting regulatory inspections and authoring or contributing to inspection responses. Strong ability to influence cross-functional stakeholders and drive compliance without direct authority. Experience with data tren