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 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.
#LI-GSK
#GSKCareers
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.
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 - usrecruitment.adjustments@gsk.com
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/
