QMS Strategy and Implementation Lead, Homeworking
PLEASE NOTE: This position in remote.
To lead the creation, publication and improvement of the Quality Management System (QMS) within the GSK Consumer Healthcare (CH) Organization, leading development of content and effective deployment of Consumer Healthcare global Standard Operating Procedures.
- Establish a sustainable strategy for QMS development, deployment, implementation, and continuous improvement.
- Ensure that the QMS is easy to use, compliant and fit-for-purpose for a business which includes a variety of product types and regulatory environments.
- Serve as Process Owner for assigned quality processes, facilitating the project work necessary to develop 'best in class' QMS content which is both compliant and efficient.
- Support Lead Subject Matter Experts in ensuring that technical details are appropriately captured in global Quality Systems SOP's and are simple, clear, and segmented where appropriate. Capture risks and issues and facilitate their resolution.
- Develop and communicate QMS performance measures.
- Continuously monitor regulatory intelligence and internal quality performance indicators. Initiate QMS changes where appropriate in response.
- Lead the network of Quality Systems professionals in Consumer Healthcare sites, functions and local operating companies.
- Lead the sharing of best practices, troubleshooting, and capability development within this community of global professionals.
- Perform other Quality Systems related duties as assigned, e.g., manage Quality Alerts and Quality Bulletins, serve as primary business process owner for pertinent workflows in the electronic document management system, assist with capability build and Quality Culture initiatives, serve as Lead SME for specific QMS topics.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in a scientific field or Regulatory Compliance, or a related discipline.
- 7+ years of experience related field.
- 7+ years Knowledge and expertise in GMP requirements for medicines, medical devices dietary supplements, cosmetics and foods as established by the major global regulators.
If you have the following characteristics, it would be a plus:
- Post-graduate study - A scientific field, Regulatory Compliance, business, or a related discipline.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk.
Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen.
*This is a job description to aide in the job posting but does not include all job evaluation details.
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