Compliance Solutions Lead

Are you excited about a role in compliance? If so, the Compliance Solutions Lead may be a role for you!

The Job Purpose

• To ensure Quality Management System (QMS), Data Verification (DV), Digital Data Analytics Compliance and Document/Submission Content  Mappings are simple, clear and readily embedded with MDS staff
• To demonstrate the above processes are operating in compliance with quality/ business expectations and to prioritize and pursue continuous improvement or significant transformation activities, where agreed and/or aligned across Medicines R&D and Vaccines R&D
• To build partnerships based on leadership and trust within and outside RMC to define and implement strategic initiatives that improve business unit core value drivers. For example, Medicines R&D and Vaccines R&D. For example, being able to triage ‘response’ assignments through the various QMS workflows through deep understanding of ‘who does what’ in Medicines R&D and Vaccines R&D.
• To integrate culture, policy and procedure, people and processes, products and patients so that quality and compliance are proactively present and embedded in efforts to deliver medicine to patients.
• Innovate using artificial intelligence and collaboration with people to streamline/transform work for minimizing level of efforts while maximizing compliance
• To develop new strategies by leading/listening/working with others to review and transform strategic compliance programs into positive business results.
• Required to work across all RMC Control Towers

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

• Build positive and productive relationships internal to GSK and with external suppliers so that quality/ compliance processes are clear, consistent, and collaborative
• Champion implementation of Internal Control Framework within MDS
• Measure the performance of MDS organization and use this data to proactively identify issues and generate solutions which improve compliance
• Lead continuous improvement efforts within MDS
• Lead and manage MDS Staff for on-time completion of QMS Implementation activities
• Author effective checks of key processes across MDS
• Lead data analysis and trending for data verification and QMS fulfilment and key metrics, detect and highlight signals through the appropriate escalation channels
• Lead sub-teams to ensure sites maintain a state of inspection readiness
• Coordinate cross control framework programs, ensuring preparedness, participation, and timely resolution of escalations, acting as local or global subject matter expert, where appropriate
• Exhibit key behaviors and communication styles that are right-sized for stakeholders and project needs
• Develop, manage, implement and communicate right-sized compliance programs and simplification initiatives as required
• Provide project management support as needed
• Support special projects and lead compliance activities at local or enterprise levels for GSK assets
• Use data analytics to enable data driven decisions and proactively identify trends, concerns/risk, etc.
• Remain current of regulatory trends and requirements, adapting practices and understanding the operational aspects and impacts of proposed solutions are key remits when engaging MDS and their external partners
• Take field assignments and/or travel, when necessary, to serve as person-in-plant or GSK representative to manage/confirm third party processes and/or deliverables are suitable for use by GSK and meet GSK requirements
• Be flexible, focused and resilient when engaging and championing multiple simultaneous initiatives while re-prioritizing work task
• Be on a GSK site for the execution of this role
• Support special projects and lead compliance activities for identifying, planning and execution quality and/or compliance solutions at RMC, MDS or enterprise levels for GSK assets

Specific Accountabilities:

QMS 

• Partner with the MDS QMS Champion and RMC Mgmt. to:
  • Partner and engage with MDS QMS Champions and SMEs for ensuring QMS Content is ‘Phase-Appropriate’ and ‘Fit-4-Phase’ for business lines in Medicines Rx
  • Train, Coach and Mentor R&D QMS SMEs for understanding QMS process, timelines and knowing when, where and what to escalate for resolution
  • Assist with annual effectiveness checks of QMS in MDS
  • Be the observer and secretary for the R&D QMS Council meeting
  • Develop and sustain the use of platform systems such as LinkME, Synthesia and Platform communications for visibility of key messages

Digital, Data Analytics (DDA) Compliance Pro