Quality Assurance Business Process Manager

The Quality Assurance Business Process Manager (BPM) supports the digital processes and supporting systems that the Quality organization interacts with.  These systems require expertise and mastery by the quality assurance unit to ensure the appropriate approvals can be completed for release of products. Examples include but are not limited to:

• SAP
• Kneat Validation system
• Lab Execution System (LES)
• Manufacturing Execution System (MES)

This includes monitoring, improvements, implementation, and training on existing and new digital systems. BPM operates in a cross-functional environment with site and Global teams with the intent to evaluate existing processes and identify improvements where practical and needed. The BPM understands how the digital platforms are deployed and the cause/effect relationship between modules.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

• Organizes and provides Quality oversight for digital tools, projects and system lifecycle
• Project manager for new implementations/changes related to in scope Business Processes
• Ensures compliance with GSK standards and policies, procedures and local regulations
• LSOP Process owner for applicable systems
• Ensure a quality mindset and looks to continuously improve upon the systems being supported.  Looks for simplification and efficiencies across digital systems and platforms
• Provide and/or facilitate training for digital processes
• Include data integrity principles upon implementation of digital tools
• Provide first line of technical support and guidance for system issues
• Single point of contact for communication with global teams and responsible for escalations and cascades
• Ensure integration and alignment of site business processes with global processes to ensure efficiency and compliance
• Attend global community meetings and cascade information to applicable groups on site
• Influence global direction and increase Hamilton visibility through consistent work with Global Business Owners
• Contributes to regulatory inspection readiness and provides Quality expertise to act as a key spokesperson during inspections/audits

Why you?

Basic Qualifications:

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

• Bachelor's Degree
• Experience with, and understanding of digital platforms such as: SAP, MES, LES, Kneat.
• Experience participating in and/or managing complex cross-functional projects.
• 10+ years of experience in a pharmaceutical/biotech/medical device industry or equivalent

Preferred Qualifications:

• Strong knowledge of cGMP and guidelines (FDA/EU/WHO)
• Good understanding of applicable regulatory requirements with demonstrated success in application.
• Strong interpersonal and people management skills.
• Demonstrated engaging, digital system implementation experience.
• Empowering and decisive leadership style.
• Well-developed relation building skills.
• Lean Six-Sigma experience.
• Excellent organizational skills, attention to detail, and ability to function in an atmosphere of constant change with detailed accuracy.
• High adaptability.
• Continuous improvement mindset and experience with operational excellence tools and principals.
• Ability to analyze data, implement changes, and monitor effectiveness.
• Sufficient technical experience and leadership ability required to implement solutions and lead discussions to gain consensus and resolution on issues/problems and associated solutions.
• Computer skills in Microsoft Office applications and ability to learn new applications.
• Demonstrated interpersonal and leadership skills.
• Effective influencing skills.
• Coaching and mentoring capabilities for shop floor training and education.

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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