About this role
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