Senior QC Leader, Biopharma Methods & Compliance

Rezolute, Inc.; Redwood City (CA); On-site; USD 185,000 - 200,000; Full time

Benefits offered by this job

Health Insurance (Medical/Dental/Visa)

401(k) Plan Match

Holiday Pay

Tracking Free Vacation Program

Educational Assistance Benefit

Fitness Center Reimbursement

Disability, Life & Long-Term Care

Job summary

Rezolute, Inc. is seeking an Associate Director of Quality Control to lead the clinical and commercial product testing program. You will partner with contract testing facilities and CMOs to ensure release and stability testing is accurate and compliant.

The role emphasizes data integrity, method transfers, and documentation governance in a fast-paced, remote-capable environment. The ideal candidate has a strong GMP background in QC/analytical science, extensive experience with LIMS and

Qualifications

• 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.

Responsibilities

• 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

Skills

GMP knowledge

Data review

Technical writing

LIMS experience

Microsoft Office

Education

Bachelor’s degree in biology/chemistry/biochemistry/microbiology

Tools

LIMS

Excel

Job description

Rezolute, Inc. is seeking an Associate Director of Quality Control to lead the clinical and commercial product testing program. You will partner with contract testing facilities and CMOs to ensure release and stability testing is accurate and compliant.

The role emphasizes data integrity, method transfers, and documentation governance in a fast-paced, remote-capable environment. The ideal candidate has a strong GMP background in QC/analytical science, extensive experience with LIMS and