Manager, Quality Assurance
Job Summary
The Manager, Quality Assurance is responsible for managing QA activities across Curevo’s clinical development programs, ensuring cGMP compliance, inspection readiness, and alignment with project and regulatory requirements within a virtual, outsourced manufacturing model. This role provides QA oversight of manufacturing, testing, and release activities performed at Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Laboratories (CTL) and ensures adherence to internal quality systems and global regulatory expectations. This position supports late-phase clinical development (Phase II/III) and Biologics License Application (BLA) enabling activities, including oversight of drug product manufacturing while coordinating timelines, risks, and cross-functional deliverables to achieve program objectives.
Key Roles And Responsibilities
Provide QA oversight of cGMP manufacturing operations and analytical testing conducted at CDMOs and CTLs
Perform QA batch record review and disposition, ensuring compliance with specifications, cGMP requirements, and regulatory expectations
Ensure compliance with U.S. and international regulatory requirements for clinical-stage products
Manage and continuously improve the Quality Management System (QMS)
Drive inspection readiness, including support for regulatory inspections and audit responses
Lead and manage deviations, CAPAs, and effectiveness checks to ensure sustainable compliance
Lead and participate in internal audits, vendor/CDMO audits, and regulatory inspections
Develop, maintain, and oversee Quality Agreements with CDMOs and CTLs
Provide ongoing QA oversight of external partners to ensure compliance with GMP and contractual expectations
Collaborate with CMC Operations, Quality Control, Regulatory Affairs, and Supply Chain to resolve quality issues and drive continuous improvement
Support program timelines, risk management, and tracking of quality deliverables
Manage and review GMP documentation supporting development, release, and lifecycle management
Lead and mentor QA staff, including training, onboarding, and professional development
Promote a strong quality culture aligned with Curevo’s clinical and regulatory objectives
Required Qualifications
BA/BS degree in science, engineering, or related field
4+ years of experience in Quality Assurance, CMC, or related field
Strong knowledge of FDA and global regulatory requirements
Expert understanding of cGMP requirements for manufacturing, analytical testing, batch review, and process validation
Experience working within an outsourced/CDMO manufacturing model
Preferred Qualifications
Experience supporting small molecule drug product manufacturing, testing, and release (clinical and/or commercial)
Experience with biologics and/or vaccine programs
Experience working with EU Qualified Persons (QPs) for batch certification and EU distribution
Experience supporting regulatory inspections and audit readiness activities
Advanced degree (MS or higher) in a relevant scientific discipline
Physical Demands
Performing the responsibilities of the job requires the ability to use hands and fingers to handle or feel and to manipulate keys on a keyboard
Occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch, or crawl
Able to read and type while sitting in front of a computer up to 4 hours at a time
Vision abilities required by this job include close vision
May occasionally have to lift, tug, and pull up to 25 lbs
Work Environment
This job operates in a professional office environment
This role routinely uses standard office equipment, including computers, phones, photocopiers, filing cabinets, and fax machines
About Curevo
Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.