Zentalis Pharmaceuticals

Director

• 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.

Associate Director, Quality Control

Clinical Operations

• Manage clinical trial study deliverables through clinical study teams and other external resources, such as contract research organizations, laboratories
• Maintain business information and timelines: ensure budgets, schedules, and performance requirements for clinical programs are met
• Create, implement, and manage clinical standard operating procedures (SOPs) that meet ICH and FDA requirements
• Ensure SOPs are followed across all programs, including with CROs, outside labs, and other third-party vendors
• Manage the activities of both internal and external resources
• Provide oversight for the establishment and maintenance of clinical trial master files and other clinical documents
• Lead clinical operations preparation for health authority inspections
• Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems
• Actively develop team capabilities and help drive staff’s individual professional growth
• Ensure effective clinical operations vendor oversight
• Other projects as deemed appropriate

Associate Director, Quality Control

Senior Director, Clinical Operations