Senior Manager, Global Quality Assurance, Technical Operations

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases.

Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas' lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab's unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease.

Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton's Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas' earlier stage programs include a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation!

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 Bio Pharma'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…