Job description
Posted Date: Aug 17 2023
Quality System Specialist – 12 Month Fixed Term Contract
Closing Date for Applications – 31st August (COB)
Reporting to the Business Development and Network Strategy Quality Manager or Director, this role supports the PSC Network Change and Business Development to ensure products and operations comply with GSK Quality expectations (QMS) and regulatory requirements. Depending on project scoping, the role will provide the support required for the oversight and management of the Quality plan relating to divestments or integration of assets.
This role will need to establish effective working relationship with the key contacts of the assigned project teams, to ensure GSK's product quality and reputation is protected during engagement of external teams to support the implementation of new External Supplier or significant changes for the existing GSK network. These include key contacts with (but are not limited to) Quality, Regulatory, Business Development, Production, Site Management and others.
The role will support improvement, standardization and management of quality systems and processes.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
In this role you will
- Management of project Quality workstream activities according to the project plans
- Contribute to compliance and quality gap analysis.
- Deliver Quality Agreements and other quality process requirements between appropriate internal and external stakeholders and signatories.
- Manage information and communications between project functions and sites.
- Escalate cGMP/Regulatory compliance issues following internal procedures and risk management requirements.
- Proactively drive a mindset of continuous improvement of processes, value creation and cost savings without compromising compliance, quality or customer service across the team. Support management of quality systems and process improvements.
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Knowledge of quality systems principles and cGMP with practical application
- Excellent organizational skills, effective time management, ability to clearly identify priorities and manage multiple tasks.
- Demonstrated ability to work and collaborate in a matrix organization, across multiple and geographic boundaries and work independently with minimal supervision.
- Technical knowledge of manufacturing, quality change and regulatory activities related to pharmaceutical products.
- Excellent verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective actions are put in place.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Good interpersonal, influencing and negotiation skills; with demonstrated ability to link to stakeholders around the business to ensure appropriate implementation and to persuade internal and external stakeholders to buy-into a specific course of action.
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Demonstrated project management skills.
- General competence in key Quality business processes: Change control, Quality Agreements, Risk Management
- Demonstrated continuous improvement behaviours and problem-solving skills.
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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