Quality & Process Manager
Roche
full-time
Posted on:
Location Type: Office
Location: Welwyn • United Kingdom
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Tech Stack
About the role
- Support Clinical Operations (CO) strategic directives by ensuring the proactive development and management of optimal business processes that enable compliance and quality standards
- Collaborate with stakeholders within Research and Early Development (pRED) and across the enterprise
- Represent CO in the respective areas of Process Management as well as Quality and Compliance in relation to GCP/GVP
- Provide strategic oversight on quality issues arising from pRED studies
- Develop and execute continuous improvements related to processes and audit/inspection findings
- Ensure pRED Quality Management System (QMS) activities aligned with global GCP/GVP QMS
Requirements
- Extensive years of experience in pharmaceutical and/or healthcare industry and drug development experience
- Demonstrates the ability proactively, Quality and Process solutions with the ability to manage emergent compliance risks
- Hold a university degree or equivalent years of experience, preferred focus in life sciences
- Possess strong working knowledge of drug development process and respective regulations
- Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
- Strong project management and process improvement skills
- Sound knowledge working with operational excellence methodologies and tools, such as value stream mapping, business process redesign, Six Sigma, LEAN, modeling and simulation, cycle time reduction, etc.
- Experience with risk management tools and processes within the clinical quality framework
- Ability to analyze, interpret and solve complex problems
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
drug developmentGCPICHRegulatory Health Authority requirementsprocess improvementrisk managementvalue stream mappingbusiness process redesignSix SigmaLEAN
Soft Skills
project managementproblem solvingcollaborationstrategic oversightcommunicationanalytical skillsproactive managementstakeholder engagementquality assuranceorganizational skills