Job Information
Community Blood Center BLA Quality & Regulatory Director in Dayton, Ohio
The BLA Quality & Regulatory Director is responsible for leading Pre-Approval Inspection (PAI) preparation activities in support of client-sponsored Biologics License Applications (BLAs), supplemental filings, and post-approval lifecycle changes. This role ensures the site generates complete, compliant, and inspection-ready documentation/facility for clients and products across varying modalities. The Director functions as the primary site authority for BLA-related quality oversight, regulatory strategy, and regulatory authority interactions, while serving as a key partner to client teams during client manufacturing inspections, scale-up, tech transfer, and commercial launch. Client-Facing BLA Leadership Serve as the primary manufacturing site Quality & Regulatory liaison to clients preparing BLA submissions or undergoing post-approval changes. Ensure alignment between site capabilities, client regulatory strategies, and filing timelines. Develops & lead execution of action plans consistent with GMP enhancements required to ensure successful client led and regulatory pre-approval inspections ahead of clinical batch manufacturing. Provide regulatory and quality guidance on: GMP enhancements required to minimize PAI and/or compliance risks. Control strategies, validation approaches, and comparability In collaboration with Quality team members, guide organization through analytical/microbiology test method strategies and stability requirements. Participate in client governance meetings, audits, and filing readiness reviews. BLA Data Package & Filing Support Lead preparation and site approval of all quality & regulatory related contract development & manufacturing organization's (CDMO) deliverables supporting client submissions, including: PPQ protocols and reports Method validation and transfer packages Batch records and executed PPQ documentation Facility, equipment, and cleaning validation documentation Stability data, characterization summaries, and control strategy elements Ensure multi-product site documentation is appropriately segregated and controlled to prevent data or client cross-contamination. Regulatory Strategy & Partner Engagement Experience supporting, leading & hosting manufacturing related health authority interactions on behalf of clients, including: Pre-Approval Inspections (PAIs) GMP surveillance inspections Regulatory questions related to facility, manufacturing, or testing Coordinate with clients and internal Quality & Regulatory Affairs team to provide prompt & accurate responses to information requests, inspection findings, or filing queries. Quality Leadership in a CDMO Environment Ensure site quality systems support multi-client, multi-product commercial GMP activities aligned with BLA requirements. Provide quality oversight for: Tech transfer and scale-up activities Manufacturing deviations, investigations, CAPA, and change controls Client-specific quality agreements and expectations Lead quality elements critical to BLA readiness, including validation, data integrity, and document management. Inspection Readiness & Regulatory Compliance Lead the site's PAI Readiness leveraging internal SMEs and client teams. Host or co-host PAIs and client regulatory inspections, ensuring alignment on: Roles and responsibilities Storyboards, document rooms, and SME preparation Shared response strategies Drive closure and remediation of inspection observations, both internal and client specific. Cross-Functional & Client Program Leadership Partners with cross functional teams such as R&D, Process Engineering, Quality Control, Quality Systems, Manufacturing, Microbiology, etc., to ensure PPQ (Process Perf