BLA Quality & Regulatory Director

About the role

The BLA Quality Assurance Director leads Pre-Approval Inspection (PAI) preparation and execution for client-sponsored Biologics License Applications (BLAs), supplemental filings, and post-approval lifecycle changes. This role drives cGMP enhancements to close compliance gaps between Human Tissue 361 HCT/P and Biologics production, ensuring successful FDA BLA Pre-Approval Inspection readiness. The Director serves as the primary site authority for BLA-related quality oversight, assessing systems, documenting gaps, and managing execution of cGMP enhancement plans. The position requires experience leading PAI inspections and interacting with the FDA post-commercialization to ensure continued compliance.

The Director will deliver BLA PAI readiness at Solvita manufacturing facilities and potential contracted or acquired sites, while also engaging client teams to build confidence in Solvita’s Biologics audit readiness capabilities.

Responsibilities

• FDA BLA PAI Inspection Readiness
  • Lead site PAI readiness activities by assessing current state, identifying gaps, developing improvement plans, and managing execution.
  • Host or co-host PAIs and client readiness inspections, ensuring alignment on roles, responsibilities, storyboards, document rooms, SME preparation, and response strategies.
  • Drive closure and remediation of inspection observations, both internal and client-specific.
• CMO Quality Leadership
  • Ensure site quality systems support multi-client, multi-product commercial GMP activities aligned with BLA requirements.
  • Provide quality oversight for tech transfer, scale-up, manufacturing deviations, investigations, CAPA, change controls, and client-specific quality agreements.
  • Lead quality elements critical to BLA readiness, including validation, data integrity, and document management.
  • Support, lead, and host manufacturing-related health authority interactions, including PAIs, GMP surveillance inspections, and regulatory queries.
  • Coordinate with clients and internal teams to provide prompt and accurate responses to information requests, inspection findings, or filing queries.
• BLA Data Package & Filing Support
  • Lead preparation and site approval of quality assurance deliverables for 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.
• Client-Facing BLA Leadership
  • 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.
  • Develop and lead execution of action plans for GMP enhancements required for successful pre-approval inspections.
  • Provide quality guidance on GMP enhancements, control strategies, validation approaches, comparability, analytical/microbiology test method strategies, and stability requirements.
  • Participate in client governance meetings, audits, and filing readiness reviews.
• Cross-Functional & Client Program Leadership
  • Partner with cross-functional teams (R&D, Process Engineering, Quality Control, Quality Systems, Manufacturing, Microbiology) to ensure PPQ readiness and commercial execution.
  • Support clients to ensure seamless quality assurance oversight across products and timelines.
  • Facilitate change control governance, ensuring transparency and impact assessments for clients and regulatory filings.
  • Lead internal/external program readiness reviews, quality deliverables, and validation milestones.

Requirements

• Education: Bachelor’s or Master’s Degree in Engineering, Chemistry, Life Sciences, or related scientific discipline.
• Experience:
  • 12+ years in Biologics Manufacturing Quality Assurance.
  • Proven leadership with direct ownership of successful BLA Pre-Approval Inspections.
  • Experience supporting client-sponsored BLA filings with a focus on manufacturing PAI compliance.
  • Experience in multi-product, multi-client environments.
  • Experience leveraging eQMS to enable compliance efficiency.
• Skills:
  • Expertise in Biologics (BLA) product manufacturing processes and interfacing with regulatory agencies during pre-approval and general inspections.
  • Knowledge of process validation (PPQ), analytical validation, control strategies, GMP commercial manufacturing quality systems, data integrity, and risk management.
  • Understanding of BLA regulatory requirements, PPQ requirements, control strategies, and comparability.
  • Strong project management and relationship management skills with cross-functional teams, external partners, and clients.
  • Effective communication and negotiation skills during audits, technical discussions, and filing strategy meetings.
  • Ability to communicate complex data effectively and lead cross-functional teams to influence decision-making.
  • High level of professionalism to represent the CMO in front of health authorities and clients.
  • Ability to research, analyze, and organize information from diverse sources and communicate with diverse audiences.

Preferred Qualifications

• Experience with contract manufacturing or managing external partners.
• Experience with ICH Q12 implementation and lifecycle management frameworks.
• Exposure to contract testing labs, modular manufacturing platforms, or single-use systems.
• Experience managing confidentiality, data segregation, and client-specific requirements.
• Project management skills, including use of project management software.
• Familiarity with domestic and international Biologics regulations.

Work Environment

Must be able to meet required physical demands with or without reasonable accommodation. Ability to travel is required.

Benefits

• Highly competitive benefits package, including medical, dental, vision, life, and supplemental insurance.
• 401(k) with employer contribution and match.
• On-Demand Pay – access to earned pay to reduce financial stress.
• Generous paid time off (PTO) – up to 5 weeks in the first year.
• Opportunities to participate in recreational activities, employee committees, and community initiatives.