GSK is currently looking for a Deviation and CAPA Manager to join our team in Rockville, MD. In this role, you will be accountable for oversight of the deviation handling and CAPA systems, ensuring continuous improvement, establishment of best practices and investigation handling capabilities.

Key Responsibilities:

• Management (timely reporting & effectiveness) of KPI’s through Inspection readiness and Site Quality Council
• Oversight of the lead investigator qualification plan
• Provides deviation and CAPA related data for Periodic Product Review
• Review and approve deviation reports, corrective actions to support GMP decisions and material disposition.
• Leading DRB to assess active investigations and deviation and CAPA metrics. Providing directions and feedback on deviation status and system health, actions, CAPA, and effectiveness checks
• Reviews SOPs and WIs and ensure SOPs meet all regulatory and QMS requirements.
• Supports Site Improvement Plans, and DMAIC Methodology roll-out at site.
• Support the site team from manufacturing and OQ for Root Cause Analysis, Report writing, and deviation tracking and provide best practices for deviation performance
• Participating to GSK’s global Community of Practice as the site’s representative
• Promoting cross-functional communication
• Improving site mentality and culture around deviation writing and management
• Site-wide trend evaluation, recurring deviations, and effectiveness of CAPA.
• Data analysis for deviation reduction
• Assess health of site quality system and addressing records based on priority. Ensuring on-time delivery and patient-focused prioritization of record closure.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS Degree in Scientific Discipline
• 5 years' experience in GMP
• Experience managing deviations and changes to processes as author, reviewer, or approver.

Preferred Qualifications:

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

• Knowledge in performance Improvement tools i.e., Six Sigma or equivalent
• Experience in advanced root cause methodologies i.e. DMAIC, 6M, Fishbone analysis.
• Good knowledge of computer software (Word, Excel, and Power Point)
• Good interpersonal skills
• Excellent oral and written communication skills.
• Ability to problem-solve and use own initiative.
• Statistical Analysis

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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