R&D Quality Manager
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Job Summary
Job Description Summary
At Sandoz our Purpose is pioneering access for patientsJob Description
The Quality Manages complex projects or late phase projects and processes to support departmental portfolio projects and objectives according to agreed timelines and standards.
Ensures that compliance with cGMP is maintained in Drug Delivery Device Development
Your Key Responsibilities:
Your responsibilities include but not limited to:
Quality responsible person for the assigned Design History File portfolio
Support quality aspects of development projects and/or processes assigned to department and assure compliance with Medical devices as well as Combination product regulations good pharmaceutical practices and Sandoz internal standards.
Support quality problems and technical matters an ensure they are re-solved consistently and in accordance with global standards and policies.
Release of medical devices and device components of combination products for clinical batch production Represent Quality Drug Delivery Device Development in initiatives and cross-divisional projects
Perform or support inspections and audits as required Approval of Deviation and OOS/OOE and change Controls in Sandoz systems
Approval in document management systems
Comply with internal and external guidelines regarding quality and safety (Quality Manual regulatory cGMP guidelines Health Authority guidance SOPs etc.).
What youll bring to the role:
Essential Requirements:
Expert knowledge in Medical Device and Combination product regulations (EU MDR FDA CFR Part 820 and Part 4 ISO 13485)
Functional Breadth - Quality Management Change Control and Audit Management
Project Management Skills - Critical Negotiations Influencing Skills and Collaboration across boundaries
Excellent communication skills in English
Youll receive:
Competitive salary Annual bonus Pension scheme Health insurance 24 days annual leave Flexible working arrangements Employee recognition scheme learning and development opportunities.
Why Sandoz
Sandoz is the global leader in Biosimilar and Generic medicines a segment of the healthcare industry that delivers 80% of the worlds medicines at 30% of the cost touching the lives of more than 1 billion people across 100 countries! While we are proud of our achievements we have an ambition to do more so that everyone can achieve the basic humanrightof good health.
With investments in new development capabilities production sites new acquisitions and partnerships wehave the opportunity toshape the future of Sandoz and help even more people gain access to low-cost high-quality medicines sustainably.
Our momentum is powered by an open collaborative culture driven by our talented and ambitious colleagues who in return for applying their skills experience an agile and collegiate environment with impactful careers where diversity of thought is welcomed and where personal growth is supported!
Join us help us make healthcare fairer and faster.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
#Sandoz
Skills Desired
Change Control Influencing Skills Knowledge Of Capa Qa (Quality Assurance) Quality Management Risk Management Root Cause Analysis (RCA) Self-Awareness Sop (Standard Operating Procedure)Required Experience:
Manager
