Serán BioScience seeks a Director, Quality Engineering & Computer System Assurance to oversee and provide strategic and operational leadership for the organization’s validation, qualification, and computerized systems assurance programs.
Requirements
- 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
- Leads initiatives to modernize validation practices
- Defines key performance indicators (KPIs) and metrics to measure effectiveness of Quality Engineering and CSA programs
- Provides Quality leadership and oversight of validation programs
- Ensures validation activities comply with internal procedures and regulatory requirements
- 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 and regulatory expectations
- Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies
- Leads initiatives to strengthen enterprise data integrity governance programs
- Provides QA oversight and approval for quality system elements impacting validated systems
- Ensures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standards
- Provides QA support for technology transfer, new product introductions, and site capital projects
- Serves as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologies
- Supports troubleshooting of complex process or system issues impacting validated systems
- Serve as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client audits
- Leads preparation and inspection readiness programs related to validation and data integrity
- Leads and develops a high-performing Quality Engineering and CSA organization
- Provides mentoring, coaching, and professional development for technical staff
Benefits
- Paid Time Off
- Retirement Plan
- Health Plans
- Life Insurance
- Disability Insurance
- Employee Assistance Program
- Pet Insurance
