R&D Quality Manager

Sandoz; Cambourne; On-site; GBP 65,000 - 90,000; Full time

Job summary

Sandoz, based in the United Kingdom, is seeking a Quality Assurance professional to provide expertise and guidance to development and research activities, ensuring compliance with GxP and regulatory requirements. You will support health authority inspections, create Quality Plans for clinical programs, and drive initiatives to improve quality and compliance across projects.

You will assist with risk management, QA reporting, CAPA investigations and remediation, and ensure training needs are

Qualifications

• Quality assurance expertise in development and research organizations to ensure compliance with regulatory requirements and Novartis procedures and quality standards.
• Experience maintaining regulatory-required files for health authority inspections and assisting with inspection management.
• Ability to generate and review Quality Plans for clinical programs and ensure QA coverage across projects.
• Experience driving quality, process and compliance improvements, including CAPA identification and execution.
• Knowledge of GxP regulations and QA training needs identified from audits and assessments.

Responsibilities

• Support health authority inspection readiness and file maintenance.
• Assist in creating and reviewing Quality Plans for clinical programs.
• Contribute to quality performance initiatives including risk management and QA reporting.
• Identify opportunities for quality and compliance improvements and develop corrective actions.
• Lead or support CAPA investigations and monitor closure and documentation.
• Manage quality aspects of projects and third-party activities, including IT validations and instrument quality.

Skills

GxP quality

Regulatory inspection support

Quality systems

CAPA

Audit management

Risk management

Process improvement

Cross-functional collaboration

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

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.