BLA Quality & Regulatory Affairs Director jobs in United States
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Solvita · 11 hours ago

BLA Quality & Regulatory Affairs Director

positionUnited States
timeFull-time
remoteRemote
seniorityDirector/Executive
date12+ years exp

Solvita is a Biologics Manufacturing company, and they are seeking a Quality & Regulatory Affairs Director with extensive experience in quality and regulatory areas. The role involves leading BLA Pre Approval Inspections and developing GMP improvement plans to ensure compliance and mitigate risks during inspections.

Non-profit Organization Management
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Comp. & Benefits
Hiring Manager
Darrell Rodriguez BSME, MBA
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Responsibilities

Proven Quality and Regulatory professional with 12+ years of experience in quality and regulatory area for a Biologics Manufacturing company, with proven track record of hosting and leading BLA Pre Approval Inspections
Able to assess, develop and lead execution of GMP improvement plans that mitigate risks of non conformances during inspections, while able to support BLA related clients
Experience supporting client sponsored BLA filings with focus on manufacturing PAI compliance is a must
Strong regulatory background with proven knowledge on process validation, test method validation, and leading Biologics manufacturing facilities through GMP improvement plans is required

Qualification

QualityRegulatory expertiseBLA Pre Approval InspectionsGMP improvement plansProcess validationTest method validationBiologics manufacturingBachelor'sMaster's DegreeClient sponsored BLA filings

Required

Proven Quality and Regulatory professional with 12+ years of experience in quality and regulatory area for a Biologics Manufacturing company
Proven track record of hosting and leading BLA Pre Approval Inspections
Able to assess, develop and lead execution of GMP improvement plans that mitigate risks of non conformances during inspections
Able to support BLA related clients
Candidate must have a Bachelors or Master Degree in Engineering, Chemistry, Life Sciences, or related scientific disciplines
Experience supporting client sponsored BLA filings with focus on manufacturing PAI compliance
Strong regulatory background with proven knowledge on process validation, test method validation
Leading Biologics manufacturing facilities through GMP improvement plans

Company

Solvita

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“Solvita comes from “sol” meaning sun and “vita” meaning life.
dateFounded in 1964
location
Dayton, Ohio, US
people-size1001-5000 employees
web-link
https://www.solvita.org

Funding

Current Stage
Late Stage

Leadership Team

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Christopher Graham
President and Chief Executive Officer
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Sarah Burns
Chief Financial Officer
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Company data provided by crunchbase