lever
Director, Quality Engineering & Computer System Assurance
Seranbio
Bend, USA
Full-time
Senior Level
Onsite
Discovered 1 weeks ago
Free
Job Fit Check
Base Career helps you apply smarter for this job.
?%
Ready to ScanFull Job Posting
- 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 QualityEngineering and CSA programs
- Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitie
- 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
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Seranbio
Quality Control Scientist II (Alternative Shift)
Bend, USA
JuniorFull Time Non Exempt
Serán BioScience is searching for an experienced Quality Control Scientist II to support an extended manufacturing schedule. This role would support all testing functions for Quality Control, primarily focused on in-proc
Discovered TodayView →
Quality Control Scientist II (Alternative Shift)
Bend, USA
Discovered TodayFull Time Non Exempt
Engineering Project Manager
Bend, USA
Discovered 1 weeks agoFull-time
Business Development Director (Regional)
, USA
Discovered 1 weeks agoFull-time
Senior Validation Engineer
Bend, USA
Discovered 1 weeks agoFull-time
Account Manager, Commercial Manufacturing
, USA
Discovered 1 weeks agoFull-time
Senior Process Engineer, Spray Drying
Bend, USA
Discovered 1 weeks agoFull-time
Quality Assurance Engineer
Bend, USA
Discovered 1 weeks agoFull-time
Project Manager
Bend, USA
Discovered 1 weeks agoFull-time