Position Summary:

Reporting to the Sr. Director of Global Quality Assurance, Clinical Development and Operations, the Director of Global Quality Assurance, GCP/GLP is responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical operations and development programs, including conducting, managing, and overseeing audits, managing quality issues, investigations, and inspections. Additionally, this role is accountable for GCP/ GLP oversight, and for assuring the compliance of studies with our Company’s Standard Operating Procedures (SOPs), policies, and all applicable global regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations); and will play a key role in process improvement, compliance, and inspection readiness.

Key Responsibilities:

• Conduct oversight activities to determine compliance with internal procedures, Clinical Research Organization (CRO) procedures and regulations by conducting audits/assessments/reviews of key processes clinical trials execution and sponsor oversight processes and providing actionable recommendations to mitigate or eliminate risks and issues identified.
• Support study teams and execute oversight activities, for example, attend study team meetings, collect and perform analysis of study health metrics, review study plans, advise study teams regarding matters of quality and compliance related to issues, risks, investigations, and CAPA’s.
• Conduct on-site, hybrid, and/or remote vendor or clinical site audits and or inspection readiness visits.
• Establish, manage, track, and provide status reports for Quality Objectives, and Priorities.
• Serve as the Quality Business Partner (QBP) point of contact for assigned functions.
• Manage ongoing QA for ongoing GCP and GLP day-to-day activities cross-functionally and serve as the quality subject matter expert on applicable regulatory requirements and guidance.
• Provide executive-level reporting of compliance risks, trends, and audit outcomes to senior leadership and governance committees.
• Ensure rapid communication of Quality issues, including potential misconduct, issues of significance with project/product for Health Authorities, business partners and senior management.
• Lead and support health authority inspections (sponsor and sites) and lead inspection readiness activities for assigned studies.
• Collaborate with clinical operations and other functions to develop and refine standard operating procedures (SOPs) related to GCP and GLP.
• Support activities related to key Quality Management System (QMS) programs, including Supplier Quality Management (SQM), audits, and inspection readiness and management.
• Monitors Quality Assurance, Clinical Operations metrics, reporting, and cross-functional review forums, including the Quality Management Review process.
• Stay current with industry trends, regulations, and best practices to ensure the organization remains compliant.
• Interact with third-party vendors and business partners to ensure compliance with Quality standards.
• Build rapport and trust with internal stakeholders in accordance with Zenas values, TRUE Innovation.

Qualifications: 

• Bachelor’s degree and 10+ years’ experience managing Quality activities related to GCP and GLP in Clinical Development and Operations in the Biopharmaceutical industry.
• Extensive knowledge of Quality Assurance principles, practices, and standards.
• GCP and GLP compliance expertise including knowledge of applicable regulatory requirements for US FDA, China, EU, and ICH.
• Comprehensive knowledge of compliance requirements and best practices for building and maintaining the systems, processes, and tools needed for Quality oversight of GCP and GLP activities in Clinical Development and Operations.
• Regulatory agency audit hosting experience.
• Experienced in leading direct reports and managing talent.
• Demonstrated ability to act 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.
• Pushes themself and others to exceed results and helps others to thrive in the face of challenge.
• When an issue arises, directs their time and energy towards resolution.
• Influences functional prioritization decisions to ensure continuous alignment with corporate objectives.
• Regularly leverages strategic relationships and networks both internally and externally.
• Understands the interdependencies between functions throughout the organization
• Embraces and demonstrates a “one team” mindset.
• Enables cooperation across teams or external partners by helping to remove and overcome barriers.
• Flexibility to work non-traditional work hours when needed, given international operations across time zones.
• Ability to travel to and work from the Zenas headquarters monthly and internationally as needed [up to 25%].

#LI-Hybrid

The position is eligible for a competitive compensation and benefits package.

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $166,600 to $208.261. 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.

Position Summary:

Reporting to the Director of Global Quality Assurance for Medical Devices and Combination Products, the Senior Manager, Global Quality Assurance – Technical Operations is responsible for providing strategic and hands‑on quality oversight for late clinical‑stage—and ultimately commercial—manufacturing activities at Zenas BioPharma’s Contract Manufacturing Organizations (CMOs). This role ensures the highest standards of GMP compliance across global operations, supports regulatory submissions and inspections, and drives continuous improvement in partnership with internal teams and external manufacturing partners. The Senior Manager will oversee batch manufacturing and testing activities, process validation, and inspection readiness to ensure robust product quality throughout the development and commercialization lifecycle.

Key Responsibilities:

• Ensure Global GMP Compliance - Maintain and enforce compliance with all applicable GMP requirements across Zenas and CMO operations, ensuring alignment with US, EU, ISO 13485, and China regulatory expectations.
• Cross‑Functional and CMO Partnership - Collaborate with internal stakeholders and external GMP partners to guide compliant execution of development, manufacturing, and supply activities, while fostering a culture of continuous improvement.
• Inspection Readiness and Regulatory Support – Support Zenas and CMO inspection readiness efforts and manage follow‑up activities related to regulatory authority inspections, ensuring timely and effective resolution of observations.
• Provide expert guidance on GMP quality assurance activities related to biologic and small molecule drug product and medical device \ combination product commercial manufacturing.
• Support the development and maintenance of internal quality systems while managing external vendors to ensure compliance and performance.
• Conduct vendor assessments, qualifications, and continuous monitoring to ensure adherence to quality and regulatory expectations.
• Support the authoring, revision, and periodic review of SOPs, policies, and controlled documents to ensure alignment with current regulatory requirements and best practices.
• Monitor local, regional, and global cGMP requirements and assess impact for the company
• Plan, execute, and document audits of CMOs and service providers involved in manufacturing, packaging/labeling, warehousing, and distribution of DS, DP, and commercial cGMP materials, including follow‑up on corrective actions.
• Collaborate closely with CMC and Technical Operations teams to provide QA support for development, scale‑up, and manufacturing activities.
• Review and approve master batch records, specifications, test methods, stability protocols, and reports
• Provide Person-In-Plant support for CMO manufacturing operations
• Review and approve executed batch records, analytical data, change controls, deviations, OOS investigations, and related GMP documentation.
• Perform batch disposition activities in accordance with applicable regulations and internal procedures.
• Participate in technical process transfers, including review and approval of commercial GMP batch records and associated documentation.
• Ensure timely communication and coordination with Operations to support uninterrupted product ensure availability
• Conduct impact assessments and approve changes in accordance with Zenas’ Change Management processes.

Qualifications:

• Bachelor’s degree with 5+ years of hands‑on experience managing Quality activities in a cGMP biopharmaceutical environment; at least 2 years of experience in medical device \ combo product functions preferred.
• Strong working knowledge of Quality Assurance principles, practices, and global regulatory standards, including US FDA GMP, EMA regulations, ICH guidelines, ISO 13485, and China GMP. Proven working experience in biopharma/pharmaceutical industry related to Quality Assurance
• Demonstrated experience in the biopharmaceutical or medical device industry with a focus on Quality Assurance for clinical and/or commercial products.
• Ability to manage workload prioritization in a fast-paced changing environment.
• Exceptional organizational skills with the ability to manage multiple tasks and deadlines effectively
• Strong interpersonal skills, written and verbal communication skills, and good team player and able to work independently
• Ability to operate as individual contributor, independently defining and driving work.
• Strong analytical and problem-solving abilities with a result-driven approach.
• Strong decision-making skills balance speed, quality, and risk delivering results under tight deadlines.
• Willingness and ability to work non‑traditional hours to support global operations across multiple time zones.

#LI-Hybrid

The position is eligible for a competitive compensation and benefits package.

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $140,800 to $176,000. 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.