System Assurance Lead

Job Title : System Assurance Lead

Location : King of Prussia, PA

Experience : 10+ Years

Duration : 12+ Months Contract

Role Overview

The System Assurance Lead will be responsible for providing leadership and oversight in Computer System Validation (CSV), system assurance, and compliance activities within a regulated life sciences environment. The role requires deep expertise in GxP validation, risk assessment, quality management, and system compliance to ensure that all computerized systems meet FDA, GxP, and other applicable regulatory standards.

The ideal candidate will have global system validation experience and a strong background in implementing and maintaining validation processes across multiple technologies and system types (e.g., SAP, MES, serialization systems).

Key Responsibilities

Lead and manage CSV and system assurance activities across GxP-regulated applications.

Perform compliance reviews for GxP systems to ensure adherence to regulatory requirements and company standards.

Oversee the end-to-end validation lifecycle, including planning, requirements gathering, risk assessment, testing, and documentation.

Author and review key validation deliverables such as Validation Plans, Functional Specifications, Test Scripts, Traceability Matrices (RTMs), and Validation Summary Reports.

Conduct and review GxP risk assessments, ensuring appropriate test coverage and traceability for all requirements.

Review and approve test protocols (pre- and post-execution) for accuracy, completeness, and adequacy of evidence.

Support change management activities, including impact assessments, implementation plans, and validation of minor system changes.

Act as the single point of contact for system assurance and compliance services across specific geographies or functions.

Ensure compliance with GAMP 5, FDA, and global regulatory guidelines.

Provide guidance to teams on validation best practices, defect management, and audit readiness.

Manage relationships with regional and functional stakeholders, addressing feedback and ensuring consistent service quality.

Collaborate with project teams using Agile or Waterfall methodologies to align validation efforts with development timelines.

Perform roles as Computer System Assurance (CSA) Lead, Validation SME, and Test Manager as required under the client's Quality Management System (QMS).

Drive service quality, performance metrics, and customer satisfaction for assigned system assurance scope.

Guide and mentor validation teams on documentation standards, regulatory expectations, and compliance strategies.

Preferred Experience

Hands-on experience with SAP Systems, MES Systems, and Product Serialization Systems in a GxP environment.

Prior experience validating systems using Agile methodology.

Experience with DMS tools and US-DSCSA implementation.

Strong understanding of Quality Management Systems and global validation practices.

Soft Skills

Excellent communication and stakeholder management skills.

Strong analytical, problem-solving, and decision-making abilities.

Proven leadership in guiding validation teams and managing multiple priorities.

Ability to work independently and collaborate effectively across cross-functional teams.