Sr. Manager, GMP QA

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual''s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.SummarySr. Manager, GMP QA will manage QA activities and manufacturing. The Sr. Manager will partner with external CDMOs to ensure quality and safety of products. Client DetailsOur client is an exciting publicly trade start up and a leader in the discovery space, focused on rare hematologic disorders.DescriptionAct as subject matter expert for GMP QA topicsConduct QA review of GMP manufacturing documents for batch disposition and product life cycle management: Batch Records, Specifications, Deviations, Change Controls, CAPA, Analytical Methods, Release and Stability TestsAssist in Quality System development; Write, revise, and periodically review SOPsParticipate in CMC team meetings and others, providing QA supportReview of master batch records, specifications, test methods, stability protocols, and reportsReview of CDMO lot disposition packagesAttend CDMO/Company joint team meetings, follow through open quality eventsManage document control system and storage of GMP documents and dataManage Audits and Qualification of GMP vendors.ProfileBachelor''s degree in Life Sciences3 years of relevant QA experienceExperience within manufacturing environmentExperience working with external vendorsExperience working in GMP EnviornmentIn-depth knowledge of FDA regulationsCommunicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customersAbility to work independentlyJob OfferCompetitive base salary and benefit packageOpportunity for career growth and developmentStock OptionsJoin a rapidly growing biotech discovery company

Created: 2021-11-29