Director, Quality Engineering & Computer System Assurance

Serán Bio Science seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization’s validation, qualification, and computerized systems assurance programs. This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.

This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.

The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.

• Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs
• Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review
• Leads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle management
• Defines key performance indicators (KPIs) and metrics to measure effectiveness of Quality Engineering and CSA programs
• Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activities

• Provides Quality leadership and oversight of validation programs including:
  • Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems

• Approval and oversight of validation lifecycle documentation including:
  • Validation Master Plans (VMP), User Requirement Specifications (URS), Functional and Design Specifications, Risk assessments, IQ/OQ/PQ protocols and reports, & Validation summary reports
• Ensures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master Plan
• Provides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environments
• Ensures validated systems maintain a continuous state of control throughout their operational lifecycle

• Supports the design and implementation of the organization’s Computer System Assurance (CSA) and Computerized System Validation (CSV) programs
• Ensures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectations
• Oversees validation lifecycle management for computerized systems including:
  • Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality management systems, Electronic Batch Record Systems, & Enterprise resource planning systems
• Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies
• Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems
• Supports system lifecycle activities including system upgrades, migrations, and decommissioning

• Provides QA oversight and approval for quality system elements impacting validated systems including:
  • Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and…