Associate Director of QA Computer Systems
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What you'll do
- Participate in the planning, execution, and oversight of the full computer system lifecycle to ensure compliance with GxP regulations
- Work across multiple departments, including QA, Clinical, Commercial, IT, Finance, and with vendors to ensure the computer systems meet the business and regulatory needs
- 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
- Maintain the validated state of the QA Computer Systems which will include validation documentation, system documentation, periodic reviews, project management, inspection support, and presentations
What they're looking for
- Extensive experience in the pharmaceutical industry, particularly working in cloud-based Computer Systems/Computer Systems Validation
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 at rezolutebio.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.
Company
Company facts come from this company's own listings. We only show what the postings themselves carry.