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.

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 Pre-Approval Inspections
• Experience supporting client-sponsored BLA filings with focus on manufacturing PAI compliance activities.
• Strong regulatory background (i.e. FDA, EMA, and ICH guidelines) including process validation, method validation, and GMP operations.
• Experience in commercial biologics manufacturing or late-stage clinical batches manufacturing.
• Experience in multi-product, multi-client environments.
• Experience leveraging eQMS to enable compliance efficiency.

Skills:

• Deep understanding of:

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  • Biologics (BLA) products manufacturing processes.
  • Main & responsible interfacing resource to regulatory agencies during pre-approval inspections.
  • Process validation (PPQ), analytical validation, and control strategies
  • eQMS experience
  • Expertise in GMP commercial manufacturing quality systems, data integrity, & risk management.
  
  
  
  

• Strong regulatory knowledge, including BLA structure, PPQ requirements, control strategies, and comparability.
• Strong authoring and critical review skills for regulatory documents.
• Ability to interpret, influence, and guide clients through evolving regulatory expectations.
• 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 discussions across business functions.
• 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 CDMO 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.

We offer:

• A highly competitive benefits package including: medical, dental, vision, life and supplemental insurance.
• 401(k) with employer contribution and match.
• On-Demand Pay - Reduce financial stress with on-demand pay access to your earned pay.
• Generous paid time off (PTO) - up to 5 weeks in your first year!
• Opportunities to participate in recreational activities, join various employee committees and give back to the community.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or other characteristic protected by law. Drug Free Workplace

Public Service Loan Forgiveness Eligible Employer