Job Purpose:  

• To ensure Quality Management System (QMS), Data Verification (DV), Quality Regulatory Intelligence (QRI), Quality Alert/Bulletins processes 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

Key Responsibilities:  

• 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 

  • Maintain currency of the Record of Scope and R&D QMS SMEs for use across all GMP/GDP functions/sites across MDS (minimum 2x per year)

  • 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

• Document/ Data Listings for Assigned Assets

  • Support delivering of Medicine Development and Supply (MDS) Project Teams for identifying the optimal use of data/ doc listings that can be further utilized by project teams for planning, timing and execution

  • Defining and implementing criteria for establishing data and document lifecycle management compliance for third parties in conjunction with MDS requirements. (is this to do with the Doc Tree otherwise remove)

  • Understanding and communicating to project teams the best way for third party deliverables to be sent GSK thru storing/archiving in compliance with GSK business and quality requirements.

• Data Verification of Submission Content

• Lead and support activities across RMC which may include but not be limited to:

  • Quality metrics generation and analyses

  • Regulatory compliance process (e.g., content verification)

  • Regulatory submission processes (e.g., review of submission content)

• Compliance metrics generation and analyses

• Role of MDS QRI Champion by receiving, assessing, distributing and communicating processes and outcomes of QRI for MDS. This will include assembly of effective checks and/or preparing QRI updates (pre-reads) for Quality Council Tier 1.

• Quality Alert/ Bulletins independent Effectiveness Check

  • Author the annual effective checks/reports for MSD QMS Implementation and MDS Quality Alert/Bulletin Annual report where required.

• General

  • Take lead roles for new activities where prototyping and first intent principles need to be developed

  • Representing RMC to internal parties and forums (risk management, quality council, change management, project teams.) and external entities (due diligence for suppliers, management monitoring) for activities and how to best align fulfillment with GSK Values

  • Remain informed of current QMS, FDA, EU, PMDA, MHRA, NMPA and other relevant industry standards and ensure their assessment of MDS compliance risks and action plans; and provide strategy and implementation recommendations for demonstrating compliance with applicable regulations

Why You?

Basic Qualifications:

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

• Bachelors Degree

• Experience of developing strategies with operational frameworks and creating & embedding new ways-of-working

• Experience leading or collaborating with fast-paced cross-functional teams in a matrix environment (horizontally and vertically) is critically important

• Experience leading and driving continuous improvement and initiatives in, compliance, risk management and quality areas

• Experience with communicating strategically and tactically the benefits of transformative/ innovative approaches across large pharmaceutical organizations

• Experience project managing complex projects involving diverse groups/ functions

Preferred Qualifications:

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

• Quality Management Systems and harmonization of compliance systems

• Experience in pharmaceutical industry

• Understands operating procedures and/or internal policies required to maintain quality standards and to protect GSK intellectual property

#LI-GSK

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 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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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