BLA Quality & Regulatory Director

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 Performance Qualifications) readiness and commercial execution.
• Able to support clients, ensuring seamless quality and regulatory oversight across different products and timelines.
• Able to facilitate change control governance ensuring transparency and impact assessments for both clients and regulatory filings.
• Lead internal/external program readiness reviews, quality deliverables, and validation milestones.

MINIMUM REQUIREMENTS


EDUCATION and/or EXPERIENCE
Education:
• Bachelor’s or Master’s Degree in Engineering, Chemistry, Life Sciences, or related scientific discipline.

Experience:
• 12+ years of Quality, Regulatory, or related experience in Biologics Manufacturing.
• Proven leadership with direct ownership of successful BLA