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Compliance Solutions Lead

4 months ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: Upper Merion, UK - Essex - Harlow, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence
Posted Date: May 6 2024

With increasing needs in Quality, Compliance, and Safety, the harmonization, simplification and acceleration of work processes and systems will deliver critical benefits to ensure delivery of the future portfolio for GSK. Supporting R&D, we are a cross-functional team with deep expertise in the Quality Management System, risk management, safety, compliance, deviation management, training, documentation, and data management. This department plays a critical role in developing our compliance strategies, transforming our technical capabilities, and driving our Quality culture, all while ensuring we maintain our License to Operate.

As Compliance Solutions Lead you will be responsible for ensuring that the Medicine Development and Supply (MDS) organization is in a compliant state with respect to regulations and GSK policies/procedures, while building a strong compliance culture in the organization. The holder will work effectively in a matrix across business functions to ensure that compliance requirements are clearly identified and understood, risks are proactively managed and mitigated, problems are rapidly and thoroughly investigated, and best practices are established.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
  • Designing and continuously improving compliance processes that will impact MDS
  • Recommending and implementing effective and sustainable solutions across the business lines
  • Being the change champion in driving compliant and effective solutions/embedding ways of workings across teams and business lines
  • Identifying compliance approaches and strategies which will ensure a 'now and future-ready' organization
  • Measuring the performance of the MDS organization and using this data to proactively identify issues, mitigate risks, and generate solutions which improve compliance and efficiency
  • Leading teams/sub-teams and supporting investigations, activities, or risk mitigation actions in areas of expertise
  • Presenting to internal R&D forums


Specific accountabilities may include:
  • Leading data analysis and trending for key metrics, detecting and highlighting signals through the appropriate escalation channels
  • Participating in appropriate Tiered Quality Councils and/or Risk Councils, including generation and analysis of data, with a focus on proactive monitoring
  • Authoring/reviewing SOPs and other documents necessary to support the Quality Management System
  • Supporting internal/external audits, including serving as Subject Matter Expert of the respective discipline
  • Driving Quality Culture initiatives within the MDS organization


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's Degree with 3+ years' experience in GxP processes supporting drug development and/or supply.
  • Experience in compliance requirements (external and/or within GSK) in operational compliance/product quality. Specifically, knowledge of the Internal Control Framework, external regulatory requirements regarding data (e.g. data integrity, ALCOA CCEA), and risk management.
  • Experience in various IT systems/solutions
  • Experience analyzing data to measure and monitor compliance and drive continuous improvement
  • Experience working in a matrix team.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Excellent communication (written and verbal) skills
  • Ability to be a champion of change within an organization and embed new ways of working.
  • Ability to closely monitor and communicate progress on daily tasks. Ability to escalate issues and recommendations to management for discussion in a timely manner.
  • Ability to understand needs of customers/stakeholders and develop solutions.
  • Experience leading a global matrix team to deliver business relevant compliance solutions
  • Experience managing scale and complexity across an organization, driving effective ways of working, interaction, and connectivity, and ensuring delivery through systems, processes, and people
  • Attention to detail, with the ability to operate at both a detailed and summary level, and to put data analysis into context by seeing the bigger picture, to spot trends and extrapolate
  • Ability to thrive in a fast-paced environment with potential for significant change


#LI-GSK

Please visit GSK US Benefits Summary t o 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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