R&D Quality Leader: Medical Devices & Combo Products

Dormont Manufacturing Co; Cambridge; On-site; GBP 55,000 - 75,000; Full time

Job summary

Sandoz Group of Companies seeks a Quality Assurance professional to ensure compliance with regulatory requirements and GxP standards in development and research operations. You will manage quality plans, audits, CAPA processes and support inspection readiness across programs.

In this role you will contribute to risk management, QA training needs, and the remediation of deviations, while collaborating with cross-functional teams and external partners to uphold quality and compliance.

Qualifications

• Functional breadth across QA and compliance.
• Proven ability in negotiations and stakeholder management.
• Strong project management capabilities.
• Collaborating across boundaries to drive cross-functional outcomes.
• Knowledge of CAPA and QA systems.
• Experience with Health Authorities audits.

Responsibilities

• Support maintenance of regulatory files for health authority inspections.
• Assist with health authority inspection management and QA planning.
• Develop and review Quality Plans for clinical programs.
• Support quality initiatives to improve performance and compliance, including risk management.
• Identify quality issues, perform root cause investigations, and help CAPA.
• Oversee quality aspects of projects and third parties; review deliverables.

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

Job description

Sandoz Group of Companies seeks a Quality Assurance professional to ensure compliance with regulatory requirements and GxP standards in development and research operations. You will manage quality plans, audits, CAPA processes and support inspection readiness across programs.

In this role you will contribute to risk management, QA training needs, and the remediation of deviations, while collaborating with cross-functional teams and external partners to uphold quality and compliance.