Associate Director, Quality Control

Bazeta; United States; Remote; USD 185,000 - 200,000; Full time

Benefits offered by this job

Health Insurance (Medical/Dental/Vison

401(k) Plan Match

Educational Assistance Benefit

Fitness Center Reimbursement

Job summary

Rezolute is seeking an Associate Director, Quality Control in the United States with remote work options to oversee testing programs, data review, and regulatory documentation. The role liaises with contract testing labs and CMOs to ensure compliance and data integrity.

The candidate will lead method lifecycle activities, manage reference standards, and contribute to IND/IMPD/BLA submissions while working in a cross-functional, remote-enabled team.

Qualifications

• Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related field.
• 6+ years in pharmaceutical/biopharmaceutical QC/analytical science environment;Biologics experience preferred.
• Proficiency in GMP analytical data review and data integrity practices.

Responsibilities

• Review raw data and summaries from contract testing facilities; provide timely feedback for necessary corrections.
• Manage reference standards and critical reagents inventory at testing facilities; oversee qualifications.
• Design and maintain analytical method monitoring programs; support method transfers and validations.
• Prepare regulatory documents and participate in annual product quality reviews.

Skills

GMP data review

Analytical method knowledge

Technical writing

LIMS familiarity

MS Office proficiency

Education

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

Tools

LIMS

Microsoft Office

Job description

# Associate Director, Quality ControlUnited States7 hours agoID 3395950$185,000 Salary## DetailsEmployment type: Full-timeRemote: YesSalary from: 185,000Salary to: 200,000Company: Rezolute## DescriptionRezolute 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. Originally posted on Himalayas Source: Himalayas (https://himalayas.app/companies/rezolute/jobs/associate-director-quality-control?utm\\_source=api)This listing comes from a partner feed. Apply on the source website.