Zentalis Pharmaceuticals

Associate Director, Quality Control

Zentalis Pharmaceuticals

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California • United States

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Salary

💰 $180,000 - $210,000 per year

Job Level

Senior

About the role

  • Oversee quality control activities performed at contract laboratories, contract manufacturing organizations, and other external testing sites.
  • Review and approve analytical data packages, including chromatographic data, dissolution results, and Certificates of Analysis, to ensure compliance with internal procedures and applicable regulatory requirements.
  • Manage and/or support Out-of-Specification (OOS), Out-of-Trend (OOT), laboratory deviation, and analytical investigation processes.
  • Participate in or manage product complaint investigations requiring analytical assessment or QC involvement.
  • Provide technical recommendations to Quality Assurance regarding lot release decisions for clinical and development batches.
  • Lead and manage the stability program, including protocol development, study initiation, data trending, reporting, and oversight of stability commitments.
  • Oversee release and stability testing to ensure timely execution and adherence to specifications and timelines.
  • Develop and maintain a stability data database.
  • Support company readiness for regulatory inspections and audits, including participation in mock inspections and preparation of QC-related documentation.
  • Participate in audits of contract laboratories, CMOs, and other vendors as needed, in collaboration with Quality Assurance.
  • Collaborate with the Analytical Development department on method transfer, qualification/validation activities, specification development, and analytical troubleshooting.
  • Review analytical sections of regulatory submissions for accuracy, consistency, and compliance with relevant guidelines.
  • Ensure all QC activities are conducted in accordance with current GMPs, ICH guidelines, USP requirements, and company procedures.
  • Contribute to the development, implementation, and continuous improvement of QC-related policies, procedures, and quality systems.

Requirements

  • Bachelor’s degree in chemistry or a related scientific discipline is required.
  • An advanced degree is preferred but not required.
  • Minimum of 8 years of relevant experience in Quality Control, Analytical Development, or related functions within the pharmaceutical industry.
  • Demonstrated experience managing outsourced laboratory activities or working directly with CMOs/CROs.
  • Strong understanding of analytical methodologies relevant to small-molecule development, including HPLC/UPLC, dissolution testing, and compendial methods.
  • Experience with stability program design, execution, and data interpretation.
  • Prior involvement in OOS/OOT investigations and analytical root-cause assessments.
  • Experience supporting regulatory inspections and interacting with regulatory agencies is preferred.
  • Experience with solid oral dosage forms is strongly preferred.
  • Familiarity with synthetic process chemistry is preferred.
  • Strong attention to detail and commitment to data integrity.
  • Ability to interpret analytical data and provide clear, scientifically sound recommendations.
  • Excellent written and verbal communication skills.
  • Ability to work effectively with external partners and internal cross-functional teams.
  • Strong organizational skills and ability to manage multiple priorities in a dynamic environment.
  • Proficiency with GMPs and applicable regulatory requirements (ICH, USP, FDA guidance).
  • Minimal travel is required to support oversight of contract laboratories, manufacturing sites, and vendor audits.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
HPLCUPLCdissolution testinganalytical methodologiesstability program designdata interpretationOOS investigationsOOT investigationsanalytical root-cause assessmentssynthetic process chemistry
Soft Skills
attention to detaildata integritywritten communicationverbal communicationcollaborationorganizational skillsability to manage multiple priorities