BLA Quality & Regulatory Director

Job description

The BLA Quality Assurance Director is 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 readiness. The Director functions as the primary site authority for BLA-related quality oversight, can assess current systems, document gaps, engages with cross functional teams via documented action plan as the basis for executional excellence, and manages execution of cGMP Enhancement plan. The position requires experience leading PAI inspections, with ability to interact with FDA post commercialization of client-sponsored products as means to ensure proper reporting of required areas in support of continued compliance. The position is expected to deliver BLA PAI readiness at current Solvita manufacturing facilities, plus possible contracted or acquired facilities based on possible scenarios to commercializing products. Last, the Director must be able to engage client teams in support of Solvita’s Commercial team, with the objective of instilling potential client(s) confidence around Solvita’s Biologics audit readiness capabilities. ESSENTIAL FUNCTIONS FDA BLA PAI Inspection Readiness • Lead selected site(s) PAI Readiness activities by assessing current state, establishing gaps, developing/communicating improvement plans, & managing improvement activities to enable executional excellence. • 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. 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 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 team to provide prompt & accurate responses to information requests, inspection findings, or filing queries. BLA Data Package & Filing Support • Lead preparation and site approval of all quality assurance related contract development & manufacturing organization’s (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. 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. • Develops & 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 ◦ Guide organization through analytical/microbiology test method strategies and stability requirements. • Participate in client governance meetings, audits, and filing readiness reviews as necessary. 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 assurance 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. MINIMUM REQUIREMENTS EDUCATION and/or EXPERIENCE 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: • Expertise in the following areas: ◦ Biologics (BLA) product manufacturing processes. ◦ Interfacing with regulatory agencies during pre-approval & general inspections. ◦ Process validation (PPQ), analytical validation, and control strategies. ◦ Expertise in GMP commercial manufacturing quality systems, data integrity, & risk management. ◦ BLA regulatory requirements. • Knowledge of PPQ requirements, control strategies, and comparability. • Project management skills. • 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 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 in managing confidentiality, data segregation, and client-specific requirements. • Project management skills, including use of project management software desired. • Familiarity with domestic and international Biologics regulations desired. WORK ENVIRONMENT and PHYSICAL ACTIVITIES Must be able to meet the required physical demands with or without reasonable accommodation. Ability to travel. 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