US-DC, Sr. Vaccine/Biologic Regulatory and Quality Affairs Subject Matter Expert 452431215191-MZ
|Senior Vaccine/Biologics Regulatory and Quality Affairs Subject Matter Expert|
Background: We have a long term contract opportunity available for one of our U.S. Federal Government clients located in Washington, DC. A Senior Regulatory & Quality Affairs Analyst is needed to provide technical advice, program management (PM) support, and mentorship to a government agency.
Duties of the position: This position will serve as a senior regulatory and quality affairs subject matter expert for multiple programs and projects involving development and manufacturing of vaccines and other countermeasures for influenza and emerging infectious diseases. Specific duties may include:
•Provide scientific/technical/program management advice for assigned programs and projects and work with the Gov./Contractor Project Team to implement Regulatory / Quality plans for assigned projects
•Development of methodologies and procedures particular to CBER vaccine and biologics products; ◦Development and management of regulated studies
◦Validation and operation of cGMP manufacturing facilities for vaccines and biologics
◦Quality assurance and regulatory compliance
•Perform site visits/audits with the government’s Contracting Officer (CO) at contractor’s facilities, and/or facilities of subcontractors to provide “man in the plant” observations
•Prepare a risk management program for the manufacturing processes ◦Inform CO of increase/decrease in risk to successful project completion
◦Generate contingency risk reduction plans
•Monitor 21CFR compliance on assigned programs and projects
•Provide review and comment on Quality Agreements
•Review supported company submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
•Participate or act as regulatory representative on various cross-functional teams, as assigned.
•Monitor supported company’s project timelines for FDA submission, and provide recommendations to overcome challenges and reduce program risk.
•Review and evaluate supported company’s Quality Program including review of company Quality Manual, Policies, and SOP’s
•Participate or lead regulatory interactions with FDA, as assigned.
•Maintain knowledge on the US competitive landscape, regulatory environment, regulations and guidances.
•Assist Project Team and supported companies to develop and manage strategy, protocols and FDA applications for Emergency Use Authorizations
•Gather knowledge and act as ombudsman before the FDA on behalf of contractors to problem solve and manage preparation to position contractors
•Review and comment on supported company regulatory strategy and documents including development plans, development study reports, study protocols and reports for GXP Quality Compliance.
•Perform GXP Quality Assessments.
•Provide Regulatory Research and Intelligence support for team as assigned.
•Provide regulatory and quality affairs expertise to support preparedness and response to emerging infectious diseases
•Support contract initiation/negotiation efforts. Participate in contract kick-off and ongoing meetings at supported company sites.
•Assess compliance with contract requirements, federal regulations and guidelines
•Prepare draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and support technical and cost evaluation for white papers/proposals
•Draft meeting minutes, trip reports, and technical assessments and recommendations on the Regulatory aspects of client-contractor interactions.
•Attend and participate in industry conferences on behalf of the Gov. customer
Education: A Ph.D. in Microbiology, Virology, Biochemistry, or Chemical Engineering
•Minimum 15 years of biologic process development, regulated studies, and/or manufacturing experience, especially vaccines and biologic products.
•Pharmaceutical experience at the Director, VP, or Sr. Manager levels.
•Knowledgeable in FDA/CBER hurdles (especially late stage) and current Good Manufacturing Practices.
•Scientific expert in vaccine/biologics regulatory and quality affairs, with extensive experience in development, manufacturing and FDA and international approval of influenza vaccines and related products.
•Experience in identifying and resolving quality, regulatory, process development or manufacturing technical problems
•Knowledge of development of manufacturing processes associated with vaccines/biologics
•Knowledgeable in routine analytical methods used to assess vaccines/biologics quality
•Ability to determine the most appropriate methodologies for the validation of the manufacturing process.
•Excellent people skills, with a team-oriented leadership approach.
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