Director, Global Quality Assurance, Technical Operations

Position Summary:

Reporting to the Sr. Director, Global Quality Assurance, the Director, Global Quality Assurance, Technical Operations will provide quality oversight of Contract Development & Manufacturing Organizations (CDMOs) involved in the production of cell banks, drug substance, drug product, and finished drug product, on behalf of Zenas BioPharma, to supply clinical trials and future commercial product to all markets. Further, this individual collaborates with internal and external parties to promote and deliver compliant Quality outcomes by working closely with CDMOs, Manufacturing, Analytical Development & Quality Control, Regulatory, Quality Management Systems, and Clinical Trial Material Management to maintain clinical drug product supply.

Key Responsibilities: 

• Provide quality oversight of the manufacturing, testing, and release of Zenas products at CDMOs and contract testing laboratories.
• Provide GMP guidance to CDMOs and Zenas Technical Operations manufacturing teams on the floor (Person-in-Plant).
• Represent Quality and quality activities from the CDMO site on Zenas project teams.
• Provide Zenas Quality support of CDMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement
• Conduct reviews and approvals (pre- and post-execution) of Master Batch Records (MBRs) and any associated supporting documentation, (such as stability and validation documentation, generation/updating of compliance dossiers etc.), to support lot disposition and prior to final assessment by a Qualified Person (QP).
• Review and approve Certificate of Testing, Certificates of Analysis, technical protocols and reports for clinical manufacturing process development, and QC assay qualification/validation.
• Serve as the main Quality contact for deviations and out-of-specification (OOS) results; initiate CAPA processes and investigate the root cause and ensure timely closure of CAPA; ensure all deviation, OOS result, and CAPA records are accurate, complete, and auditable; and compile and analyze the deviation, OOS, and CAPA data for future improvement.
• Ensure rapid communication of Quality issues, including issues of significant deviations with project/products, to business partners and senior management.
• Monitor metrics, reporting, and support cross-functional review forums, including the Quality Management Review process.
• Build and maintain the Quality processes needed to support Quality oversight of Technical Operations deliverables, including but not limited to supplier management, tech transfer, production (master cell bank, drug substance, drug product, combination products, etc.), packaging, labeling, lot disposition, change control, and deviations, while ensuring all deliverables are inspection ready and compliant with applicable regulatory requirements.
• Support activities related to key Quality Management System (QMS) systems, processes, tools, training, programs, and governance, including the eQMS, computer system validation, Quality management review (QMR), supplier Quality management (SQM), internal and external audit, inspection readiness and management, training, and document control.
• Engage with cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement, drive issue resolution.
• Author and implement Quality procedures, and training.
• Meet with Quality, Production, Regulatory, and Logistics personnel at the CDMO sites as necessary or during regularly scheduled meetings for issues relating to Zenas products.
• Identify compliance gaps and improvement opportunities to inform the corporate Quality Plan and/or Inspection Readiness plans.
• Manage inspection-readiness activities and regulatory inspections from regulatory agencies or third parties.
• Support inspections, global submissions, and dossier approvals.
• Support and perform internal and external CDMO quality audits.
• Develop and maintain Quality Technical Agreements.

Qualifications: 

• Minimum of 12+ years of pharmaceutical quality assurance experience in a GMP manufacturing environment.
• Bachelors’ degree in life sciences, engineering, or related field.
• Extensive knowledge of Quality Assurance principles, practices, and standards (e.g., US FDA GMP, EMA, and ICH Guidelines, etc.).
• GxP compliance expertise including knowledge of applicable regulatory requirements for US FDA, China, EU, and ICH.
• Demonstrated ability to function as both a functional leader and an individual contributor capable of defining and driving work independently.
• Efficacy and efficiency in making and acting on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.
• Flexibility to work non-traditional work hours when needed, given international operations across time zones.
• Able to successfully manage workload and timelines.
• Familiarity with basic project management tools.
• Strong project management, problem-solving, and analytical skills.
• Ability to travel to and work from CDMO sites, and or the Zenas headquarters, and internationally as needed [up to 35%].

#LI-Remote  

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $180,000 to $220,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance, and/or location. 

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.