Senior Director, Quality Assurance Job at Theradaptive (Frederick)

Job Description

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.

Job Responsibility

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)
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
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
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
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
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)
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
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

Requirements

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
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
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)
Expert-level knowledge of: ICH Q7, Q8, Q9, Q10, Q11 guidelines
Expert-level knowledge of: ISO 14971 (Risk Management), ISO 10993 (Biocompatibility)
Expert-level knowledge of: 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

Nice to have

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

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