Senior Quality Assurance Engineer Lead

Job Description Summary

Location: Carlsbad, California (on-site)

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. We are looking for an experienced pharmaceutical industry professional with Manufacturing and Quality experience to join the team at our new Carlsbad site.

As the Senior Quality Assurance Engineer Lead, you will be responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the Carlsbad RLT manufacturing site.

 

Job Description

Key Responsibilities:

• Ensure Quality and Compliance aspects of design and work in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure that the facility is:
  • Compliant with all Novartis QMS and appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing.
  • Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications.
  • Capable to meet intended design goals of output volume, turnaround time and operating and product costs.
• Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).
• Provides oversight of the Computerized System Validation Lifecycle efforts to ensure compliance with 21 CFR Part 11, EudraLex Annex 11, and applicable FDA/EMA Guidance's on electronic data integrity Contributes to design of facility, utilities and process equipment from a Quality and Compliance perspective.
• Participate in development and implementation of validation strategies, policies, and other documentation for CSV systems and IT applications. Provide Quality oversight, review, and approve Validation Documentation including but not limited to: Validation Master Plan, User Requirements, Functional Requirements, Installation Qualification, Operational Qualification, Performance Qualification, Trace Matrix, Validation Summary Reports, and Change Controls.
• Support cross-functional team risk assessments to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
• Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration). Review and approve change controls, SOPs, Deviations, and CAPAs associated with qualification/validation execution to ensure effectiveness of actions.
•  Ensure that vendor assessments, audits and quality agreements (if required) of suppliers of GxP computer software are in place
• Lead and support internal self-inspections.
• Ensure all quality personnel, including contractors, consultants …