Compliance Solutions Lead
GSK Consumer Healthcare
King Of Prussia, PA
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 building 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 SLM organization, including QZIP program oversight
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s Degree and a minimum 3+ years’ experience in GxP processes supporting drug development and/or supply
Excellent (Written) skills
Working knowledge of 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.
Skilled in various IT systems/solutions
Experience analyzing data to measure and monitor compliance and drive continuous improvement
Experience working in a matrix team
If you have the following characteristics, it would be a plus:
Excellent communication skills (verbal)
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 working in 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
Strong relationship builder
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
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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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