BLA Quality & Regulatory Director

We are looking for an experienced BLA Quality Assurance Director who would be 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.

The Director functions as the primary site authority for BLA-related quality oversight, can assess current systems, document gaps, and engage with cross-functional teams via documented action plans as the basis for executional excellence. The position requires proven ability in leading PAI inspections, with ability to interact with FDA post-commercialization of client-sponsored products as a means to ensure proper reporting of required areas in support of continued compliance.

The Director must also engage client teams in support of Solvita's Commercial teams as an enabler of commercial activities and must have the ability to instill client confidence around Solvita's Biologics audit readiness.

Essential Functions
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 & 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.
  • Analytical/microbiology test method strategies and stability requirements.
  
  
  
  
• Participate in client governance meetings, audits, and filing readiness reviews as necessary.

BLA Data Package & Filing Support

• Lead preparation and site approval of all quality assurance-related contract development & manufacturing organization (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.

Quality Leadership in a CMO 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.
• 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 teams to provide prompt & accurate responses to information requests, inspection findings, or filing queries.

FDA PAI Inspection Readiness Compliance

• Lead the site's PAI readiness leveraging internal SMEs and cross-functional teams.
• 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.

Cross-Functional & Client Program Leadership

• Partner 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.
• Support clients to ensure seamless quality assurance oversight across different products and timelines.
• 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

• Bachelor's or Master's Degree in Engineering, Chemistry, Life Sciences, or related scientific discipline.

Experience

• 12+ years of experience in Biologics Manufacturing Quality Assurance.
• Proven leadership with direct ownership of successful BLA Pre-Approval Inspections.
• Experience supporting client-sponsored BLA filings with focus on manufacturing PAI compliance activities.
• Experience in multi-product, multi-client environments.
• Experience leveraging eQMS to enable compliance efficiency.

Skills

• Understanding of:
  
  
  
  • Biologics (BLA) product manufacturing processes
  • Interfacing with regulatory agencies during pre-approval inspections
  • Process validation (PPQ), analytical validation, and control strategies
  • GMP commercial manufacturing quality systems, data integrity, & risk management
  
  
  
  
• Knowledge of BLA structure, PPQ requirements, control strategies, and comparability.
• Strong 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 effectively through data, with conclusions visualized & simplified to enable engaging cross-functional discussions.
• Proven ability to lead cross-functional teams, manage priorities across multiple programs, and influence decision-making.
• High level of professionalism and ability to represent the CMO in front of health authorities & clients.
• Ability to research, manipulate, analyze, integrate, and organize information from diverse sources.
• Ability to communicate with diverse audiences, cultures, and personnel.

Preferred Experience

• 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 & Physical Activities

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