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.
Key Responsibilities
* 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 and ensure they are resolved 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 deviations, 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.).
Qualifications
* 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.
Benefits
Competitive salary, annual bonus, pension scheme, health insurance, 24 days annual leave, flexible working arrangements, employee recognition scheme, learning and development opportunities.
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.
#J-18808-Ljbffr