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