BLA Quality & Regulatory Director

• GMP surveillance inspections

The BLA Quality Assurance Director is responsible for leading Pre-Approval Inspection (PAI) preparation & execution activities in support of client-sponsored Biologics License Applications (BLAs), supplemental filings, and post-approval lifecycle changes. This role leads the manufacturing site(s) through cGMP enhancements to close possible gaps between Human Tissue 361 HCT/P vs Biologics production compliance, leading to successful FDA BLA Pre-Approval Inspection readiness. The Director functions as the primary site authority for BLA-related quality oversight, can assess current systems, document gaps, engages with cross functional teams via documented action plan as the basis for executional excellence, and manages execution of cGMP Enhancement plan.

The position requires experience leading PAI inspections, with ability to interact with FDA post commercialization of client-sponsored products as means to ensure proper reporting of required areas in support of continued compliance. The position is expected to deliver BLA PAI readiness at current Solvita manufacturing facilities, plus possible contracted or acquired facilities based on possible scenarios to commercializing products. Last, the Director must be able to engage client teams in support of Solvita’s Commercial team, with the objective of instilling potential client(s) confidence around Solvita’s Biologics audit readiness capabilities.

• Lead selected site(s) PAI Readiness activities by assessing current state, establishing gaps, developing/communicating improvement plans, & managing improvement activities to enable executional excellence.
• Host or co-host PAIs and client readiness 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.

• 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.
• 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 Assurance team to provide prompt & accurate responses to information requests, inspection findings, or filing queries.

• Lead preparation and site approval of all quality assurance related contract development & manufacturing organization’s (CMO) 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.

• Serve as the manufacturing site Quality Assurance 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 drive successful pre-approval inspections.
• Provide quality guidance on:
  • GMP enhancements required to minimize PAI and/or compliance risks.
  • Control strategies, validation approaches, and comparability
  • Guide organization through analytical/microbiology test method strategies and stability requirements.
• Participate in client governance meetings, audits, and filing readiness reviews as necessary.