R&D Quality Manager (Medical Devices andor Combination Products)

Job Description Summary

Job Description

Major accountabilities:

• Support maintenance of the regulatory-required files for health authority inspections and assist with health authority inspection management
• Support generation of Quality Plans (and review other plans for quality/safety aspects) for clinical programs
• Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management health authority reporting IT systems
• Support initiatives focused on quality process and compliance improvement including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements -Ensure information gained during quality and compliance initiatives as well as audit and assessment results are evaluated to identify any regulatory compliance and QA training needs -Aid in the identification of quality issues and assist with root cause investigations and Support the development of corrective and preventative action plans (CAPA) including monitoring status to Ensure issues are addressed completed and documented.
• Provide assistance in the remediation of deviations Ensure follow up and monitoring of associated corrective and preventive actions.
• Manage and Support quality aspects of projects and activities including those related to third parties analytical instruments manufacturing equipment quality plans training IT validations etc. -Review and approve quality deliverables to ensure compliance (including procedures records third party work contractors clinical trial material components gap assessments )
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Clusters Quality System in place and continuously updated as required risks proactively identified and effectively mitigated -The number and severity issues identified during internal and external audits.
• Demonstrated/recognized leader of specific GxP; early external/industry engagement -Sufficient financial knowledge (e.g. cost management budget forecast etc.) -Role Model of Sandoz culture values and behaviors

Minimum Requirements:
Work Experience:

• Functional Breadth.
• Critical Negotiations.
• Project Management.
• Collaborating across boundaries.
• Skills:
• Agility.
• Analytical Development.
• Audit Management.
• Auditing.
• Business Partnering.
• Change Control.
• Continuous 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 Expertise.

Languages :

• English.

EEO Statement:

Sandoz Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

Sandoz Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please connect with us outling the job requisition number in your message.

Salary Range

Skills Desired