Associate Director – QA Computer Systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the planning, execution, and documentation of validation for both new and existing systems, encompassing EDMS, QMS, ERP, and RIM.

• Develop, implement, and authorize validation deliverables such as validation plans, risk assessments, requirements documentation, test scripts, trace matrices, and summary reports.

• Recognize opportunities to enhance and scale validation processes suitable for a small, rapidly growing company.

• Ensure that principles of data integrity are integrated into the processes of computerized systems.

• Assist with vendor qualification and inspection tasks.

• Lead the ongoing maintenance of system lifecycles, which includes risk assessments, change control processes, audits, and periodic reviews.

• Manage vendor contracts and licensing for computer systems as necessary.

• Collaborate with IT to enhance the computer systems experience for end users.

• Work in partnership with QA, Clinical, Commercial, IT, Finance, and vendors.

• Preserve the validated status of QA computer systems through documentation, periodic reviews, project management, inspection support, and presentations.

⛳️ Requirements

• A Bachelor's degree in computer science, information technology, engineering, or a related field (or equivalent experience).

• Strong knowledge of FDA 21 CFR Part 11, GAMP 5, and EU GMP Annex 11.

• A minimum of 10 years’ experience in computer system validation within regulated industries.

• Familiarity with validation methodologies, tools, and industry best practices.

• Experience using Veeva Vault.

• Demonstrated experience in quality assurance, validation, or the implementation of Veeva Systems applications.

• Understanding of FDA 21 CFR Part 11, EMA Annex 11, and GxP regulations.

• Proven background in quality assurance, software testing, or IT quality.

• Knowledge of software development lifecycle (SDLC) methodologies.

• Willingness to travel up to 15% of the time.

• Certification as a Veeva Vault Administrator or similar credentials is advantageous.

• Experience in managing both employees and contractors.

• Familiarity with multiple GxP systems and their implementations.

• Expertise in electronic validation management is a plus.

• Proficient in SharePoint, MS-Word, Excel, PowerPoint, and Adobe Acrobat.

🏝️ Benefits

• Annual performance bonus.

• Health Insurance (Medical / Dental / Vision).

• Disability, Life & Long-Term Care Insurance.

• Holiday Pay.

• Tracking Free Vacation Program.

• 401(k) Plan Match.

• Educational Assistance Benefit.

• Fitness Center Reimbursement.