Associate Director of QA Computer Systems

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.

Rezolute ’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders.

More information can be found atrezolutebio.com

Overview

The Associate Director of QA Computer Systems will participate in the planning, execution, and oversight of the full computer system lifecycle to ensure compliance with GxP regulations. As a key member of a growing pharmaceutical company, this individual will work across multiple departments, including QA, Clinical, Commercial, IT, Finance, and with vendors to ensure the computer systems meet the business and regulatory needs. This role will work with a core team on the ongoing and dynamic needs of the QA Computer Systems processes as the company transitions from the clinical to the commercial phase.

This position will be part of a team that is responsible for maintaining the validated state of the QA Computer Systems which will include validation documentation, system documentation, periodic reviews, project management, inspection support, and presentations.

The ideal candidate for this role has extensive experience in the pharmaceutical industry, particularly working in cloud-based Computer Systems/Computer Systems Validation.

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 t