Associate Director of QA Computer Systems

Principle Duties and Responsibilities: Lead validation planning, execution, and documentation for new and existing systems (e.g. EDMS, QMS, ERP, RIM).

Create, execute, approve validation deliverables (e.g. validation plans, risk assessments, requirements, test scripts, trace matrices, summary reports).

Identify opportunities to streamline and scale validation processes appropriate for a small, fast-growing company.

Ensure data integrity principles are incorporated into the computerized system processes.

Support vendor qualification and inspection activities.

Lead ongoing system lifecycle maintenance to include risk assessments, change controls, audits and periodic reviews.

Manage vendor contracts and licensing for computer systems where applicable

Work with IT to support and improve end users’ experience of computer systems

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

Strong understanding of regulatory requirements and guidelines, such as FDA 21 CFR Part 11, GAMP 5, and EU GMP Annex 11.

10+ years’ experience in computer system validation in regulated industries, with knowledge of validation methodologies, tools, and best practices.

Experience with Veeva Vault

Proven experience in quality assurance, validation, or implementation of Veeva Systems applications.

Familiarity with regulatory requirements and guidelines applicable to the life sciences industry, such as FDA 21 CFR Part 11, EMA Annex 11, and GxP regulations.

Proven experience in quality assurance, software testing, or IT quality

Knowledge of software development lifecycle (SDLC) methodologies.

Excellent analytical, problem-solving, and decision-making skills.

Effective communication and collaboration abilities, with the capability to work closely with cross-functional teams and stakeholders.

Attention to detail, with a focus on accuracy, thoroughness, and quality.

Ability to travel up to 15% of the time

Preferred Experience, Special Skills and Knowledge -

Certification in Veeva Vault Administrator or similar credentials is a plus.

Experience managing employees and contractors

Familiarity with multiple GxP systems and system implementations

Adaptable – Operates effectively in a fast-paced, biotech environment

Expertise in electronic validation management is a plus

Proficiency in SharePoint, MS-Word, Excel, PowerPoint, and Adobe Acrobat