Director, Quality Engineering & Computer System Assurance

The Director, Quality Engineering & Computer System Assurance will 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.

Requirements

• Develops and implements the site strategy for Quality Engineering and Computer System Assurance (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, and manufacturing automation systems
• Supports the design and implementation of the organization’s Computer System Assurance (CSA) and Computerized System Validation (CSV) programs
• Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems
• 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
• 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 Account
• Health Plans
• Basic Life Insurance
• Long-term Disability Insurance
• Employee Assistance Program
• Pet Insurance