Associate Director Quality Control

Zentalis•Island or Peninsula of San Diego, CA

About The Position

Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a potentially first-in-class and best-in-class WEE1 inhibitor for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC). Azenosertib is being evaluated as a monotherapy and in combination across multiple tumor types in clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types. The Company is also leveraging its extensive experience and capabilities to translate its science to advance research on additional areas of opportunity for azenosertib outside PROC. The Associate Director, Quality Control, is responsible for overseeing all quality control activities performed at external laboratories in support of the Company’s small-molecule, solid oral dosage development program. This individual will manage outsourced testing operations, ensure the accuracy and integrity of analytical data, lead QC-related investigations, and oversee the Company’s stability program. The position will work closely with Quality Assurance, Analytical Development, and external partners to support phase-appropriate analytical controls and readiness for commercial operations. This is an individual-contributor leadership role with significant cross-functional interaction and high visibility within the organization.

Requirements

Bachelor’s degree in chemistry or a related scientific discipline is 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.
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.

Nice To Haves

An advanced degree is preferred but not required.
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.

Responsibilities

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.