R&D Quality Manager
R&D Quality Manager
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Job Description
Job Description Summary
-Provide quality assurance expertise guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects including Quality Plan initiatives and processes that support quality objectives to assure their compliance with GxP regulations.Job Description
Key responsibilities:
Support discipline/service provision individually or within a team; provide functional expertise to QA/Line Units as needed.
Review approve and release GMP-relevant deliverables and tools to ensure cGMP compliance.
Manage project-related activities (e.g. process/quality initiatives facility upgrades IT validation) as per responsibility.
Ensure compliance with internal/external quality and safety guidelines (e.g. GMP SOPs Quality Manual).
Drive continuous quality improvements for manufacturing collaborating with production engineering and supply chain.
Oversee qualification/validation of processes equipment facilities and software for GMP use.
Review and approve GMP documents including URS IQ/OQ/PQ Change Controls CAPAs and SOPs.
Support inspection preparations and maintain oversight of external maintenance and qualification activities.
Essential requirements:
Degree in Pharmacy Biology Chemistry Engineering or equivalent.
Fluency in English (verbal and written).
Strong awareness of quality issues and urgency in task completion.
Open and clear collaboration and communication skills.
Scientific technical and regulatory knowledge in the specific area with basic understanding of drug development.
Detailed knowledge of cGMP and familiarity with safety/environmental regulations.
Minimum 5 years of experience in pharmaceutical companies in equivalent roles.
Strong organizational skills.
Why Novartis Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: will receive: You can find everything you need to know about our benefits and rewards in the Novartis Life
:// to Diversity and Inclusion: Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities join the Novartis Network here: Desired
Agility Analytical Development Auditing Audit Management Business Partnering Change Control Continued Learning Health Authorities Influencing Skills Knowledge Of Capa Qa (Quality Assurance) Quality Management Risk Management Root Cause Analysis (RCA) Self-Awareness Six Sigma Sop (Standard Operating Procedure) Technological ExpertiseRequired Experience:
Manager
Employment Type
Full-Time
