Associate Director, Quality Control

Employer posted

21 Oct 2026

Last confirmed open

Not yet confirmed

Source

Job board

Degree

Degree preferred

“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 p”

Visa

Not stated

“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.”

Timezone

Not stated

Languages

Not stated

Location evidence

“Remote — United States”

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