Key Responsibilities
Develop and incorporate effective processes and procedures and may contribute to business processes and procedures.
Assure computer systems meet regulatory requirements and that they conform to regulatory expectations.
May interact with regulators.
Support/Manage routine computer compliance assessments (internal & external)
as well as computer compliance initiatives of demanding high priority including regulatory inspections and high-risk non-compliance issues.
May lead initiatives, program, or team activities, as required.
May be responsible for coaching, mentoring, training others.
Identify computer related business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
Contribute to or lead the training, education, guidance and influencing of GSK R&D staff on best quality and computer compliance policy and practices.
Assure compliance with computer compliance regulations and expectations and
GSKs related policies and procedures.
Provide computer compliance advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK.
Represent CSQA as a primary business contact.
Identify and mitigate computer compliance risks to GSK through effective assessments and/or via providing advice and consultancy to QA and business units regionally and globally.
Liaise with customers to provide computer compliance advice/input.
Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments.
Establish improvement processes, as needed, or set specific measurable targets and goals linked to GSK business needs.
Any other duties relevant to, and consistent with, the level of responsibility of the job, as required by management
Education Requirements
Bachelor’s degree in a relevant scientific or engineering discipline or equivalent combination of education, training and experience. Advanced degree preferred.
Job Related Experience
Demonstrable knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations
Communications are clear, concise, well structured, authentic and easily understood.
Communicates and interacts at most levels both inside and outside of GSK.
May influence and negotiate at most levels and may interact with regulators.
Build and maintain effective internal GSK business relationships
Other Job-Related Skills
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.
Ability to make complex ideas, simple.
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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