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 Quality Control Director is responsible for contract laboratory oversight to ensure the quality, accuracy, and compliance of testing and analytical services provided by external contract laboratories. This position is responsible for establishing and maintaining effective quality control processes, overseeing laboratory performance, and ensuring that all testing activities meet regulatory requirements, industry standards, and company specifications. The QC Director leads the Quality Control staff at Rezolute and collaborates with Manufacturing Science & Technology (MS&T) group. This role provides a critical interface with the broader Rezolute organization and global vendors, providing Quality Control oversight and collaborating on GMP execution to support advancement of biologics and small molecule programs including development of QC method lifecycle activities.

Responsibilities

• Management of QC functions – Lead Quality Control department and activities for clinical and commercial products, including management of in-process, release and stability testing of GMP Biologics and small molecule products.
• Contract Laboratory Selection/Qualification and Maintenace: Collaborate with the Quality Compliance team to identify, evaluate, select, qualify, and maintain contract laboratories capable of providing testing services aligned with organizational needs and requirements.
• Quality Control Processes: Establish and implement robust quality control processes for the oversight of contract laboratories, including but not limited to test method verification, data review, and deviation management.
• Method Validation and Transfer: In partnership with the contract laboratories, oversee method validation and transfer activities between contract laboratories, ensuring the accuracy, reliability, and consistency of test methods and results across sites.
• Performance Monitoring: Monitor and evaluate the performance of contract laboratories through regular assessments, and performance metrics to ensure adherence to quality standards, regulatory requirements, and service level agreements (SLAs).
• Data Review and Approval: Oversee the review and approval of analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both release and stability testing.
• Investigation and Issue Resolution: Investigate and address deviations, out-of-specification (OOS) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with contract laboratories and internal stakeholders to implement corrective and preventive actions (CAPAs).
• Regulatory Compliance: Ensure that contract laboratory testing activities comply with applicable regulatory requirements, including but not limited to FDA regulations (e.g., cGMP, GLP), and industry guidelines (e.g., USP, EP).
• Continuous Improvement: Identify opportunities for process optimization, efficiency gains, and quality enhancements in contract laboratory oversight processes. Implement best practices, training programs, and quality initiatives to improve performance and mitigate risks.
• Stability Program – Own the stability programs, with regard to program design, data analysis, trending and regulatory submissions. Review/approve technical reports to support investigations and expiry/retest periods.
• Reference Standards – Oversee the qualification and maintenance of reference standards for all Rezolute programs.
• Method Performance – Develop and implement performance metrics to monitor the health and status of QC method performance; develop and implement improvement where indicated by the data.
• Regulatory Inspections – Provide technical support for product related regulatory inspections.
• Regulatory Submissions – Author relevant sections of regulatory submissions and response materials (e.g., IMPD, IND, MAA, BLA); interface with regulatory agencies on all components of stability and reference standard programs and analytical method qualification and validation.

Qualifications

• Bachelor of Science with 15+ years of relevant experience in biotechnology/pharmaceutical industry
• Experience in managing and overseeing contract laboratories, including vendor selection and performance monitoring
• Direct experience with analytical method development, qualification, validation and transfer as well as product characterization and analytical comparability
• Direct experience managing stability programs, including establishing expiry and justification of expiry extension
• Direct experience with authoring and review of Module 3 CTD content; experience interfacing with international health authorities
• Comprehensive knowledge of current Good Manufacturing Practices (cGMPs) and multi-national regulations
• Excellent written, verbal communication and presentation skills
• Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues
• Excellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement

Preferred Experience, Special Skills and Knowledge

• Certification in quality management (e.g., Six Sigma, ASQ) or relevant professional 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 Quality Control Director role could range from $190,000 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.