Key Responsibilities
Propose strategy, policy and objectives that fundamentally raise the importance of computer system quality/compliance within R&D.
Interact with and influence regulators and/or industry experts to represent GSK interests.
Interpret and apply computer system related regulations/policies/expectations to unique and often complex issues.
Lead within a dynamic matrixed environment by setting standards, objectives and measurements to drive business results and build a performance-based culture.
Manage, as necessary, priorities, schedules and/or initiatives to assure delivery of objectives.
Encourage an environment that will optimize staff productivity and added value to the organization.
Develop CSQA skill sets and knowledge base to meet the needs of a changing compliance environment.
Responsible for analysis, assessment, management, and communication of inherent and emerging computer compliance risks to GSK management.
Assure communication and escalation of risks and solutions.
Responsible for mitigation of risks.
Propose strategies to build supportive, developmental environment. Create ways for others to coach, mentor and give constructive feedback to each other.
Provide strategic vision and leadership oversight and direct one or more of the following, as required:
A cross-matrix team
Sponsor or lead initiatives.
Maintain strategic contact with business groups and represent the QuRE externally.
Identify potential computer compliance risks by interpreting changes in the internal and external regulatory environment and translate the impact to GSK.
Monitor external landscape and uses external network to assess GSK's quality and computer compliance risks.
Identify risks relating to computer systems compliance and leads/drives change related to business and/or regulatory on a global scale.
Design and develop mutual solutions to issues that show measurable improvement on key indicators and added value to external/internal customers.
Support/manage routine computer compliance assessments (internal & external)
as well as computer compliance initiatives and support regulatory inspections as required.
Any other duties relevant to, and consistent with, the level of responsibility of the job, as required by CSQA Management.
Education Requirements
Bachelor’s degree in a relevant scientific or engineering discipline or equivalent combination of education, training and experience.
Advanced degree preferred.
Other Job-Related Skills
Preferred years of experience 20 + years
High degree of organizational awareness and in-depth knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations
Good understanding of medical/corporate governance principles and demonstrated ability to develop sound solutions for complex problems.
Communicate with clarity, impact and passion, tailored to the audience.
Use multiple media to deliver powerful messages.
Ability to make complex ideas, simple.
Ability to influence and negotiate at various levels internal and external to GSK.
Interact with regulators.
Create an environment where open, transparent communication, especially providing and receiving feedback, is valued and trusted.
Create an environment of empowerment and remove barriers to empowered action.
Effectively utilize internal and external networks to influence key stakeholders.
Ability to understand and integrate diverse opinions and perspectives in setting and delivering business objectives.
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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