Associate Director, Quality Control — Biopharma Lead

Rezolute; United States; À distance; USD 185 000 - 200 000; Plein temps

Avantages offerts par ce poste

Health Insurance (Medical/Dental/Vison

Disability, Life & Long-Term Care

Holiday Pay

Tracking Free Vacation Program

401(k) Plan Match

Educational Assistance Benefit

Fitness Center Reimbursement

Résumé du poste

Rezolute is seeking an Associate Director, Quality Control to manage the clinical and commercial product testing program and serve as the QC SME with contract testing labs and CMO partners.

The role oversees data review, reference standards, method lifecycle, change controls, and regulatory submissions, ensuring GMP compliance. Base salary ranges from $185,000 to $200,000, with eligibility for an annual bonus, depending on location and qualifications.

Qualifications

• Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related field.
• 6+ years in pharmaceutical/biopharmaceutical Quality Control/Analytical Science.
• Detailed knowledge of analytical techniques and compendial methods for proteins and small molecules.
• Proficiency in GMP analytical data review.
• Familiarity with lab investigations for OOT/OOS results.
• Knowledge of GMP principles and regulatory guidance.
• Experience authoring method protocols, reports, SOPs and Quality System records.

Responsabilités

• Review raw data and summaries from contract testing facilities.
• Provide timely feedback for corrections to raw data and summaries.
• Perform electronic data entry and verification.
• Maintain inventory of reference standards and reagents at CTL facilities.
• Manage qualification/requalification of reference standards and reagents.
• Design and maintain the analytical method monitoring program.
• Recommend improvements to existing test methods.
• Transfer test methods to contract labs; review protocols and reports.
• Help develop/validate new test methods.
• Review QC system deviations, investigations, and change controls.
• Author and revise QC SOPs and related documents.
• Submit QC documents to the electronic document management system.
• Support regulatory filings data verification.

Connaissances

Quality Control

GMP data review

Technical writing

Regulatory knowledge

Detail-oriented

Formation

Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related field

Outils

LIMS system

Microsoft Office Suite

Description du poste

Rezolute is seeking an Associate Director, Quality Control to manage the clinical and commercial product testing program and serve as the QC SME with contract testing labs and CMO partners.

The role oversees data review, reference standards, method lifecycle, change controls, and regulatory submissions, ensuring GMP compliance. Base salary ranges from $185,000 to $200,000, with eligibility for an annual bonus, depending on location and qualifications.