BLA Quality & Regulatory Director

About the role

The BLA Quality Assurance Director leads Pre-Approval Inspection (PAI) preparation and execution activities for client-sponsored Biologics License Applications (BLAs), supplemental filings, and post-approval lifecycle changes. This role ensures manufacturing sites achieve cGMP compliance, bridging gaps between Human Tissue 361 HCT/P and Biologics production standards to prepare for successful FDA BLA Pre-Approval Inspections. The Director serves as the primary site authority for BLA-related quality oversight, assessing systems, documenting gaps, and driving cross-functional action plans to achieve executional excellence.

Responsibilities

• Lead site PAI readiness activities: assess current state, identify gaps, develop and communicate improvement plans, and manage execution to ensure readiness.
• 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.
• 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 Quality Assurance teams to provide prompt and accurate responses to information requests, inspection findings, or filing queries.
• Lead preparation and site approval of all QA-related CMO deliverables supporting client submissions, such as PPQ protocols/reports, method validation packages, batch records, validation documentation, stability data, and control strategy elements.
• Ensure multi-product site documentation is appropriately segregated to prevent data or client cross-contamination.
• Serve as the manufacturing site QA liaison to clients preparing BLA submissions or undergoing post-approval changes, ensuring alignment between site capabilities, client regulatory strategies, and filing timelines.
• Develop and execute action plans for GMP enhancements to minimize PAI and compliance risks.
• Provide quality guidance on control strategies, validation approaches, comparability, analytical/microbiology test method strategies, and stability requirements.
• Participate in client governance meetings, audits, and filing readiness reviews.
• 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 QA 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

• Bachelor’s or Master’s Degree in Engineering, Chemistry, Life Sciences, or related scientific discipline.
• 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 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, and BLA regulatory requirements.
• Expertise in GMP commercial manufacturing quality systems, data integrity, and risk management.
• Understanding of 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.
• Ability to communicate with diverse audiences, cultures, and personnel.

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.

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 your first year.
• Opportunities to participate in recreational activities, employee committees, and community initiatives.

Work Environment

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