Manages clinical and commercial product testing through contract laboratories and manufacturing partners. Oversees GMP data review, reference standards, critical reagents, analytical method lifecycle activities, quality system records, investigations, SOPs, regulatory filing support, and product quality reviews. Serves as a Quality Control subject matter expert and coordinates analytical testing, method transfers, and compliance activities across internal and external teams.
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI)
Position Description
This position is responsible for management of Rezolute’s clinical and commercial product testing program. The Associate Director, Quality Control acts as a liaison between Rezolute and its contract test laboratory (CTL) / CMO partners who perform our release and stability testing. The successful candidate will support Rezolute’s objectives by acting as a Quality Control subject matter expert during internal stakeholder collaborations and external team meetings.
Principle Duties and Responsibilities Include:
Manage data review program
- Review raw data and data summaries provided by contract testing facilities
- Provide timely feedback to testing laboratories regarding necessary corrections to raw data and summaries
- Perform electronic data entry and verification
Manage reference standard and critical reagent program
- Maintain inventory of reference standards and critical reagents at contract testing facilities
- Manage the qualification and requalification of new reference standards and critical reagents
Manage analytical method lifecycle
- Design and maintain the analytical method monitoring program
- Recommend improvements to existing test methods
- Manage the transfer of test methods to contract laboratories including review and approval of protocols and reports
- Participate in the development and validation of new test methods
Initiate and review Quality System records
- Review deviations, OOS/OOT investigations, supplier change notices and change control records as Quality Control subject matter expert
- Author, review and revise Quality Control SOPs
- Manage submission of Quality Control documents into electronic document management system
Support regulatory filings
- Participate in the preparation of regulatory documents (e.g., IND, IMPD, BLA, NDA, MAA) and requests for information including data verification of content
- Participate in the preparation of Annual Product Quality Reviews including data verification of content
• Other duties as assigned
Qualifications/Requirements:
- Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related field
- 6+ years in pharmaceutical/biopharmaceutical Quality Control / Analytical Science environment; experience with biologics preferred
- Detailed knowledge of analytical techniques and compendial methods used for testing of proteins and small molecules
- Proficiency in GMP analytical data review
- Demonstrated understanding of laboratory investigation methodology for OOT and OOS results
- Demonstrated knowledge of GMP principles and regulatory guidance
- Competent technical writer with expertise in authoring method protocols and reports as well as SOPs and Quality System records (deviations, investigations, change controls)
- Prior use of a LIMS application or electronic database
- Proficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, Teams, etc.)
- Data-driven mindset with eye for detail
- Robust problem-solving abilities
- Capable of maintaining direction while working independently
- Ability to identify and adapt to changing priorities: determine what matters most
- Ability to articulate issues to management in a timely manner
- Self-motivated: ability to interact with a multi-disciplinary remote-based team
- Effective written and verbal communication skills
Preferred Experience, Special Skills and Knowledge:
- Previous partnership with external contract laboratory to coordinate activities between sponsor and service provider
- Prior author of regulatory submissions of IND, IMPD, BLA, NDA, MAA
- Previous contribution to annual product quality review (APQR) process
Rezolute (RZLT) currently anticipates the base salary for the Associate Director Quality Control role could range from $185,000 to $200,000 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.
Rezolute, Inc. Redwood, California, USA Office
275 Shoreline Dr, Redwood, CA , United States, 94065
Similar Jobs
Cloud • Fintech • Food • Information Technology • Software • Hospitality
Lead Toast’s lending product strategy and roadmap, including Toast Capital and Easy Pay. Partner with engineering, design, data science, credit, legal, finance, marketing, and external financial partners to develop, launch, and optimize B2B financial products. Responsibilities include defining requirements, managing backlogs, facilitating agile ceremonies, building business cases, gathering customer feedback, and measuring product outcomes.
Top Skills:
SQL
Cloud • Information Technology • Consulting
Manages and grows a portfolio of enterprise and upper mid-market clients by driving revenue, retention, and expansion. Owns client relationships, develops account strategies, manages sales opportunities through close, and aligns managed cloud and professional services to business outcomes. Builds senior stakeholder relationships, coordinates cross-functional delivery teams, monitors account health, maintains pipeline discipline, and ensures forecasting accuracy and strong customer experience.
Top Skills:
AWSAzureGCPVMware
Cloud • Information Technology • Consulting
Owns and grows strategic enterprise client portfolios for managed and professional services. Builds C-suite relationships, develops account strategies, drives revenue expansion and retention, leads complex multi-year engagements through close, and aligns cross-functional teams to deliver measurable business outcomes. Serves as the primary client accountability and executive escalation point while maintaining pipeline, forecasting, and account planning discipline.
Top Skills:
AWSAzureGCPHybrid CloudPrivate CloudPublic CloudVMware
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
