R&D Quality Leader — Medical Devices & Combination Products

GB69 (FCRS = GB069) Sandoz Ltd.; Cambridge; On-site; GBP 40,000 - 60,000; Full time

Job summary

GB69 (FCRS = GB069) Sandoz Ltd. in Cambridge is seeking a Quality Assurance specialist responsible for ensuring compliance with applicable regulations and quality standards. You'll manage projects that support quality objectives and provide expertise to operational activities.

The ideal candidate must demonstrate strong quality management skills and experience in project management. A commitment to regulatory compliance and quality improvement is essential.

Qualifications

• Work Experience: Functional breadth, critical negotiations, project management, collaborating across boundaries.
• Languages: English.

Responsibilities

• Support maintenance of regulatory-required files for health authority inspections.
• Assist with health authority inspection management.
• Support generation of quality plans for clinical programs.
• Ensure information gained during quality initiatives are evaluated.
• Manage and support quality aspects of projects and activities.

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

GB69 (FCRS = GB069) Sandoz Ltd. in Cambridge is seeking a Quality Assurance specialist responsible for ensuring compliance with applicable regulations and quality standards. You'll manage projects that support quality objectives and provide expertise to operational activities.

The ideal candidate must demonstrate strong quality management skills and experience in project management. A commitment to regulatory compliance and quality improvement is essential.