Senior Director, Quality Assurance

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in‑class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of biology and tissue repair. Our lead therapeutics are in the following indications: Spinal Fusion Long Bone Repair Osteochondral Repair Dental and Facial Bone Repair Immuno‑Oncology We are an innovative, fast‑paced team that is advancing a diverse array of cutting‑edge translational research projects. Position Summary The Senior Director of Quality is an senior organizational leader responsible for establishing, maintaining, and continuously improving the company's integrated Quality Management System (QMS) across both the biological/drug component and the medical device component of the combination product. This individual will serve as the organization's quality authority, partnering closely with Regulatory Affairs, R&D, Manufacturing, Clinical Operations, and Supply Chain to ensure product safety, efficacy, and compliance throughout the entire product lifecycle — from design controls through post‑market surveillance. This is a highly visible, cross‑functional leadership role that requires both strategic vision and hands‑on expertise. The ideal candidate brings deep experience in both drug/biologic and device quality systems, and a demonstrated ability to build and scale a quality culture in a dynamic, fast‑growing environment. Responsibilities Quality Management System (QMS) Design, implement, and own an integrated QMS that satisfies 21 CFR Parts 210/211 (drug/biologic GMP), 21 CFR Part 820 / ISO 13485:2016 (medical device QMS), and ICH guidelines (Q7, Q8, Q9, Q10). Ensure the QMS addresses the regulatory designation of the combination product (PMOA‑based lead center: CDRH or CDER) and the requirements of the non‑lead center. Develop and maintain all quality policies, SOPs, work instructions, and quality plans across the product lifecycle. Drive QMS digital transformation initiatives, including electronic quality management platforms (e.g., Veeva Vault QMS, MasterControl, TrackWise). Combination Product Compliance Serve as the company's subject‑matter expert on 21 CFR Part 3 (combination product designation), 21 CFR Part 4 (regulation of combination products), and applicable guidance documents. Lead cross‑functional efforts to align quality requirements for both the protein growth factor drug/biologic constituent and the device constituent part throughout CMC development, scale‑up, and commercialization. Oversee the integration of device design controls (21 CFR 820.30) with drug development quality requirements, ensuring alignment in risk management activities per ISO 14971. Regulatory Affairs Partnership Collaborate closely with Regulatory Affairs on BLA, PMA, 510(k), or De Novo submission strategies — specifically quality module content (Module 3 / CTD, Design History File, Device Master Record). Prepare and lead quality‑related FDA interactions including pre‑submission meetings, Agency responses, and inspection readiness activities. Support compliance with EU MDR 2017/745, IVDR, and country‑specific registration requirements for international expansion. Manufacturing Quality & Supplier Management Establish and maintain robust supplier qualification and management programs for both biological raw materials (e.g., cell banks, media, excipients) and device components (e.g., delivery device, packaging). Oversee quality oversight of CMOs and CDMOs, including audit programs, quality agreements, and batch release processes for both drug substance/drug product and finished device. Lead batch record review and disposition activities; authorize release of finished combination product. Champion contamination control strategies and sterility assurance programs for sterile combination products. Risk Management & CAPA Own the enterprise risk management framework, including risk‑based approaches for process validation (IQ/OQ/PQ), equipment qualification, and change control. Drive a robust CAPA system with effectiveness checks; ensure root cause analysis methodologies (fishbone, 5‑Why, FMEA) are applied consistently. Oversee complaint handling, adverse event reporting (MDR/MedWatch), and post‑market surveillance programs. Clinical & Non‑Clinical Quality Oversight Ensure GCP compliance and quality oversight for IND/IDE‑enabling studies, Phase I–III clinical trials, and any combination product‑specific clinical evaluations. Support GLP oversight for non‑clinical studies (biocompatibility per ISO 10993, toxicology, PK/PD). Inspection Readiness & Regulatory Intelligence Maintain a state of continuous inspection readiness for FDA Pre‑Approval Inspections (PAI), Establishment Inspections, and notified body audits. Monitor the regulatory landscape (FDA guidance, ISO updates, ICH harmonization) and proactively update quality systems accordingly. People Leadership & Culture Build, mentor, and retain a high‑performing quality team across QA, QC, Regulatory CMC, and Quality Systems functions. Foster a quality culture of accountability, transparency, and continuous improvement across all departments. Define headcount and budget requirements to scale the quality organization in alignment with pipeline milestones and business objectives. Qualifications Education Bachelor’s degree (required) in Life Sciences, Biomedical Engineering, Chemistry, Biochemistry, or a related field. Advanced degree (M.S., Ph.D., or M.D.) strongly preferred. Experience 15+ years of progressive quality experience in the biopharmaceutical, biotech, or medtech industry, with at least 5 years in a senior leadership role (Director level or above). Demonstrated experience with combination products, including working knowledge of both drug/biologic and device QMS frameworks. Direct experience managing FDA inspections (PAI, cGMP, QSR) and responding to 483 observations and Warning Letters. Hands‑on experience with protein biologics or growth factors (e.g., rhPDGF, BMP, FGF, EGF, VEGF) in a GMP manufacturing or quality context. Experience with sterile or aseptic combination products is highly preferred. Regulatory & Technical Knowledge Expert‑level knowledge of 21 CFR Parts 210/211 (Drug cGMP), 21 CFR Part 820 / ISO 13485 (Device QMS), 21 CFR Part 4 (Combination Products), ICH Q7, Q8, Q9, Q10, Q11 guidelines, ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), CTD/eCTD Module 3 quality documentation and BLA/PMA submission experience. Working knowledge of EU MDR 2017/745 and CE marking processes for device constituent parts. Preferred Qualifications Experience with growth factor‑eluting wound care devices, orthobiologics, or tissue‑engineered products. Familiarity with Pre‑Submission (Q‑Sub) meetings and FDA’s combination product review process (OCP). ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or RAC certification. Experience implementing electronic QMS platforms (Veeva Vault, MasterControl, Pilgrim SmartSolve). Prior experience at a company that has successfully commercialized a combination product or biologic. Strong publication or presentation record in quality, regulatory, or combination product‑related forums. Position Location On‑site at Theradaptive corporate headquarters and laboratory in Frederick, MD. Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non‑disqualifying disability, or any other characteristic protected by law. #J-18808-Ljbffr Theradaptive, Inc.