Deviation Local Process Owner

GSK; Marietta (PA); On-site; USD 110,000 - 160,000; Full time

Job summary

GSK in Marietta, PA seeks the Deviation Local Process Owner to oversee deviation and CAPA systems, ensuring robust investigations and corrective actions across the site. You will coordinate with quality, manufacturing, regulatory, and supply chain to maintain inspection readiness and continuous improvement.

You will lead training, mentor staff, and drive KPI-based improvements, applying risk-based thinking and strong communication to support regulatory expectations and quality governance.

Qualifications

• Bachelor’s degree and 5–8+ years in pharmaceutical or regulated industry in Quality
• Proven experience leading deviation investigations and CAPAs
• Ability to act independently with risk-based thinking in alignment with cGMP and regulatory expectations
• Experience supporting regulatory inspections and writing inspection responses
• Strong influencing skills across cross-functional teams

Responsibilities

• Act as site-level system owner and SME for deviation and CAPA systems, ensuring compliance
• Own local deviation and CAPA system performance incl. KPI development and trend analysis
• Lead inspection readiness activities and inspector interactions
• Deliver training on deviation and CAPA systems and procedures
• Mentor site system users with root cause analysis and investigation guidance
• Collaborate with operations to improve system metrics and KPIs
• Lead continuous improvement and simplification initiatives with measurable outcomes
• Ensure activities comply with GMP and regulatory requirements and are inspection-ready
• Coordinate with regulatory and audit teams for inspections and follow-ups
• Partner with regional/global quality teams to harmonize practices

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

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

Tools

Quality Management Systems

Electronic deviation tracking tools

Job description

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.
• Responsible for delivering training activities on deviation and CAPA systems and procedures (Qualified Trainer).
• 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 trending, KPI development, and management review reporting.
• Experience managing deviations or non-conformance processes within regulated manufacturing.
• Strong knowledge of Good Manufacturing Practices (GMP) and U.S. regulatory quality expectations.
• Proven ability to lead investigations, perform root cause analysis, and drive corrective and preventive actions.
• Strong communication skills to engage and influence cross-functional teams and external partners.

Preferred Qualifications

• Experience as a deviation or quality process owner in a large pharmaceutical or life sciences organization.
• Familiarity with quality management systems and electronic deviation tracking tools.
• Experience contributing to quality system harmonization and continuous improvement initiatives.
• Exposure to regulatory inspections and handling audit-related deviation follow-ups.
• Demonstrated ability to work collaboratively in cross-functional and multi-location teams.

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Technical Writing

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.

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.