Remote Senior Quality Assurance Engineer Lead Job in United States Novartis

Who you are

• B.S. degree and 6+ years of GxP pharmaceutical manufacturing experience
• 2+ years of quality assurance experience
• Knowledge and application of CFR’s and cGMP’s
• Experience with FDA and EU regulations and US/international regulatory agency inspections
• Experience leading internal audits and providing closure reports
• Experience with commissioning, qualification, and validation to meet FDA and other health authority requirements
• Experience with deviations, CAPAs, and Change Controls
• Experience reviewing/authoring standard operating procedures and partner with operations on product investigations
• Experience leading people
• Excellent oral and written communication skills with technical writing experience
• Ability in long-term project planning, team building, budgeting, and operational excellence

Desirables

• B.S. in Engineering, Chemistry or Biochemistry
• Sterile manufacturing experience preferred

What the job involves

• Responsible for design, construction, validation, maintenance, and compliance of facilities, systems, and processes at Carlsbad RLT manufacturing site
• Ensure Quality and Compliance aspects of design and work with Engineering, Manufacturing Operations, and consultants
• Provide strategic quality input on translating commercial product requirements into technical solutions and oversee Computerized System Validation Lifecycle