IT Quality Management
Posted on :
24-11-2024
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1 Vacancy
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Job Description
- Using initiative and a self-driven approach to identify and deliver continuous improvement opportunities, the lead will be encouraged to:
- Ensure that all IT systems used by sites remain compliant throughout their lifecycle, with the relevant compliance policies, standards and government regulations.
- Drive and deliver improvements in our Compliance performance through Lean and automation to continuously improve Quality Management services.
- Identify, communicate, and lead trends in operational compliance risks, breaches, and issues, ensuring CAPA to mitigate the risks are discussed and agreed with Collaborators
- Drive the continuous monitoring, improvement and digitisation of our processes, services and tools, through applying LEAN thinking and techniques, and exploiting tools and automation.
- Apply specialist knowledge to support critical thinking around how to run compliance activities in the IT organisation.
- Skills required:
- Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes Oxley
- Extensive experience in multiple areas of quality and compliance within a Pharmaceutical/Biotech environment
- Developing quality, compliance and risk strategies and articulating the strategic direction for regulated organisations
- Experience of running Quality and Compliance across functions and geographies in large, sophisticated and sometimes uncertain IT environments, leading business and IT partners from across the business
- Continuous improvement/Compliance Improvement
- Internal auditing and external regulatory inspection management
- Shown challenge, negotiation & influencing capabilities.
- Strong Change Management Leadership
Employment Type
Full-time
Key Skills
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