The BLA Quality & Regulatory Director leads all Quality and CMC (Chemistry, Manufacturing & Controls) regulatory activities that support 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 for multiple clients and products across varying modalities. The Director functions as the primary site authority for BLA-related quality oversight, regulatory strategy, and health authority interactions, while serving as a key partner to client teams during development, scale-up, tech transfer, and commercial launch.
Key Responsibilities
Client & Regulatory Leadership
- Serve as the primary Quality & Regulatory liaison for clients preparing BLA/MAA submissions and postapproval changes.
- Ensure alignment between site capabilities, regulatory strategies, and filing timelines.
- Provide guidance on CMC expectations, including control strategies, validation, method readiness, and stability.
BLA Data & Filing Support
- Oversee the preparation, review, and approval of all site deliverables supporting client submissions such as PPQ protocols/reports, method validation packages, batch records, and validation documentation.
- Ensure proper segregation and control of multiclient documentation.
Regulatory Strategy & Health Authority Engagement
- Provide CMC regulatory guidance to internal teams and clients.
- Support or lead interactions related to FDA/EMA inspections, including PAIs and GMP surveillance activities.
- Coordinate responses to regulatory information requests and inspection findings.
Quality Oversight
- Ensure quality systems support commercial GMP activities aligned with BLA expectations.
- Provide oversight of tech transfers, investigations, deviations, CAPA, and change controls.
- Support client quality agreements and drive readiness for validation and data integrity requirements.
Inspection Readiness
- Lead the site's PAI readiness program and host or cohost inspections.
- Coordinate SME preparation, document room management, and response strategies.
- Drive timely closure of inspection observations.
CrossFunctional Collaboration
- Partner with Manufacturing, Quality Control, R&D, Process Engineering, and other functions to ensure PPQ and commercial readiness.
- Support multiple client programs simultaneously while maintaining consistent quality and regulatory oversight.
Minimum Requirements
Education:
Bachelor's or Master's degree in Engineering, Chemistry, Life Sciences, or related scientific discipline.
Advanced degrees (MS, PhD, PharmaD) preferred
Experience:
5+ to 10 years of Quality, Regulatory CMC, or related experience in Biologics Manufacturing.
Strong background with FDA, EMA, and ICH guidelines, including process validation, method validation, and GMP operations.
Experience with FDA/EMA inspections, especially Pre-Approval Inspections (PAI).
Demonstrated experience in multi-product, multi-client environments.
Skills:
- Expertise in biologics manufacturing, GMP commercial operations, and CMC regulatory frameworks (FDA, EMA, ICH).
- Strong command of process validation (PPQ), analytical validation, control strategies, and BLA/CMC documentation.
- Advanced authoring and critical review skills for regulatory submissions, with the ability to interpret evolving regulatory expectations.
- Proven leadership in guiding crossfunctional teams, managing complex program priorities, and influencing decisionmaking.
- Effective communication and negotiation skills for audits, technical discussions, and interactions with health authorities.
- Strong relationshipbuilding skills with internal teams, external partners, and clients.
- Highlevel analytical ability to research, integrate, and organize complex information across diverse audiences and cultures.
Work Environment and Physical Activities
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
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Solvita
paid time off, 401(k)
Jan 20, 2026