Senior Manager, Global Quality Assurance, Technical Operations

Zenas BioPharma • Waltham, MA

8d • Hybrid

About The Position

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.

Requirements

• 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.

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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees