Zentalis Pharmaceuticals · 1 day ago
Associate Director Quality Control
San Diego, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
$180K/yr - $210K/yr
8+ years expZentalis Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer treatments. The Associate Director, Quality Control, is responsible for overseeing quality control activities at external laboratories and ensuring compliance with regulatory requirements while managing outsourced testing operations.
BiopharmaBiotechnologyPharmaceutical
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
Qualification
Required
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
Preferred
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
Company
Zentalis Pharmaceuticals
Zentalis is a pharmaceutical company focused on developing clinical therapeutics for cancer patients.
51-200 employees
H1B Sponsorship
Zentalis Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$896.6MKey Investors
PfizerMatrix Capital
2023-06-15Post Ipo Equity· $235.5M
2022-05-16Post Ipo Equity· $200.2M
2022-04-27Post Ipo Equity· $25M
Leadership Team
Kim Blackwell
Chief Executive Officer
Melissa Epperly
CFO
Recent News
2025-11-11
Company data provided by crunchbase