Location: Remote

Company Description

• Rezolute is a late stage clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance
• Rezolute is preparing to initiate a global Phase 3 trial for their lead clinical asset, RZ358, which is a potential treatment for Congenital Hyperinsulinism (CHI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas
• The company’s second clinical-stage asset, currently in Phase 2, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
• More information can be found at rezolutebio.com

Position Description

The Associate Director/Director, Quality Assurance Computer Systems will be responsible for ensuring the quality and reliability of GxP information technology (IT) systems, software applications, and digital products within Rezolute. This role will involve designing, implementing, and executing QA processes to ensure compliance with quality standards, and enhance user experience across various IT projects. A primary responsibility is to ensure that GxP computer systems used at Rezolute comply with regulatory requirements and meet the highest standards of quality and reliability. The Associate Director/Director, Quality Assurance Computer Systems is responsible for leading the validation and maintenance of GxP computer systems throughout their lifecycle, from initial development to retirement, to ensure data integrity, accuracy, and security. A focus responsibility includes ensuring the quality, compliance, and optimal performance of Veeva Systems applications. The Associate Director/Director, Quality Assurance Computer Systems will lead the designing, implementing, and executing of QA processes specific to Veeva applications, collaborating with the business IT lead, QA Compliance, and cross-functional teams to support system configuration, validation, and continuous improvement initiatives.

Responsibilities

• Quality Assurance Processes: Develop, implement, and maintain QA processes and procedures for IT Systems applications, ensuring adherence to regulatory requirements (e.g., FDA, EMA), industry standards (e.g., GxP), and company policies.
• Compliance Assurance: Ensure that IT systems and software applications comply with regulatory requirements, industry standards, and best practices., (e.g., FDA, EMA), industry standards (e.g., GxP), and company policies.
• Validation Planning: Develop and execute validation strategies and plans for computer systems in compliance with regulatory requirements, industry standards, and company policies.
• System Documentation: Create and maintain validation documentation, including user requirements specifications (URS), functional specifications (FS), design specifications (DS), test protocols (IQ/OQ/PQ), data migration plans, validation summary reports, and change control documentation.
• Risk Assessment: Conduct risk assessments to identify and prioritize validation activities based on the criticality of the system, potential impact on product quality, patient safety, and regulatory compliance.
• Change Control Management: Implement and manage change control processes for IT applications, including assessing change impact, documenting change requests, coordinating testing activities, migration of data, and ensuring proper documentation and validation of changes.
• Regression Testing: Perform regression testing to ensure that software updates, enhancements, and configuration changes do not adversely impact existing functionality or system integrity.
• Vendor Management: Collaborate with vendors and external partners to ensure that third-party systems and software meet validation requirements and integrate seamlessly into the company’s quality management system.
• Compliance Monitoring: Conduct periodic reviews and audits of validated systems to ensure ongoing compliance with regulatory requirements, company policies, and industry best practices.
• Continuous Improvement: Identify opportunities for process improvement and optimization in computer system validation activities to enhance efficiency, effectiveness, and compliance.

Qualifications

• Bachelor’s degree in computer science, information technology, engineering, or a related field
• Strong understanding of regulatory requirements and guidelines, such as FDA 21 CFR Part 11, GAMP 5, and EU GMP Annex 11
• 15+ years’ experience in computer system validation in regulated industries, with knowledge of validation methodologies, tools, and best practices
• 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 management roles
• 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

Preferred Experience, Special Skills and Knowledge

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

Other

• Ability to travel up to 20% of the time

To Apply

Interested and qualified candidates should send their resume to recruiting@rezolutebio.com to the attention of Human Resources.

Rezolute (RZLT) currently anticipates the base salary for the Associate Director/Director, Quality Assurance Computer Systems role could range from $170,000 to $225,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical / Dental / Vision)
• Disability, Life & Long-Term Care Insurance
• Holiday Pay
• Tracking Free Vacation Program
• 401(k) Plan Match
• Educational Assistance Benefit
• Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.