Senior Quality Lead/ Manufacturing CSA QA

We have a current opportunity for a Senior Quality Lead/ Manufacturing CSA QA on a permanent basis. The position will be based in Philadelphia, PA with a hybrid model. For further information about this position please apply and see the below:

Key Responsibilities:

• Possesses comprehensive knowledge of regulations related to the implementation and use of computerized systems across all GxP areas.
• Participates in system implementation project teams, offering guidance on System Lifecycle activities and validation strategies using a risk-based approach aligned with FDA CSA.
• Develops and presents the Quality Assurance Plan for a large, multi-year manufacturing site, following the FDA CSA approach.
• Consults with Quality team members and relevant internal stakeholders to identify and define high-risk areas, focusing on patient safety, product quality, and data integrity.
• Identifies and escalates areas of risk or non-compliance to the manager or leadership team.
• Provides support for regulatory inspection preparedness activities as needed.

Key Qualification:

• Bachelor's degree and relevant GxP work experience
• Minimum of 10 years of experience of relevant experience in CSV/CSA
• Must be strategic and a high-level thinker who knows CSV/CSA, and very strong in data integrity/ALCOA principles
• Experience performing Quality Assurance function related to Computerized Systems / Infrastructure
• Proficiency with regulations related to FDA / MHRA regulations
• Experience with validation of Enterprise / Lab Computerized Systems
• Quality metrics, dashboards, analysis and improvement programs
• Ability to guide and ensure client compliance with industry best practices and regulations.
• Proficiency in using Microsoft Office Applications