R&D Quality Manager (Medical Devices and/or Combination Products)

Sandoz; 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

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

• 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 outlining the job requisition number in your message.