Quality Manager (GMP)

Position Summary:

The Quality Manager (GMP) will be responsible for performing and managing day-to-day activities surrounding manufacture, testing and disposition for clinical study material. This will play a key role in overseeing all quality-related aspects of our outsourced manufacturing processes. This position is responsible for ensuring that products meet internal quality standards and comply with applicable regulatory requirements (e.g., FDA, EMA, GMP). As a liaison between the company and our contract manufacturing organization (CMO), the QA Manager will manage quality systems, review and approve batch records, handle deviations, and ensure proper documentation practices.

Key Responsibilities:

• Review of key manufacturing deliverables including MBRs, EBRs, Specifications, CoAs, Change Controls, Deviations, etc.
• Support management of External Vendor qualifications, including facilitation and/or execution of Vendor Audits primarily supporting manufacturing operations.
• Assist with management of Quality Investigations.
• Creation, implementation, administration of cross-functional UPB Quality Systems.
• Author and/or facilitate authoring and review of QMS documents across functional areas (including SOPs, Forms, Quality Investigations, etc.).
• Coordinate ongoing QMS training including organization and archival of associated documentation.
• Perform quality trends analysis and reports. Ability to analyze data to recommend continual improvements opportunities.

Qualifications:

• Bachelor’s Degree in related scientific field.
• 5 years of experience in biotech/pharmaceutical industry.
• Biotech or pharma industry experience is strongly preferred.
• Excellent verbal and written communication skills.
• Demonstrated ability to work collaboratively across functions.
• Combination product experience is desired.
• Ability to travel up to 10-15% supporting audit and vendor management.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com.