Pave Talent is hiring on behalf of our client, an innovative biotech company addressing critical unmet needs in breast reconstruction. After a highly successful exit to Boston Scientific, they're now pioneering combination drug-device products that could dramatically reduce infection rates for breast cancer patients—from 7-15% down to single digits.
About Our Client
Our client is an established, cash-positive biotech company with 26 dedicated team members based in Gaithersburg, Maryland. They're known for their innovative, collaborative, and patient-focused culture. With multiple commercialized products generating revenue and fresh capital from their recent successful asset sale, they offer the financial stability of an established company with the exciting challenge of building something new.
The Challenge & Your Impact
This is a newly created Director of Quality role where you'll have the rare opportunity to establish and scale quality systems for a brand-new manufacturing facility in Gaithersburg. You'll be the quality expert—building upon an existing QMS framework while adapting it for combination drug-device products that are entering FDA submission phases.
You'll work cross-functionally with a lean, talented R&D, Regulatory, and Operations team to establish compliant processes from facility qualification through commercial launch. This isn't a role where you'll be buried in bureaucracy—you'll be hands-on, strategic, and empowered to make decisions that directly impact patient outcomes.
Your Key Responsibilities
Design and implement quality systems compliant with 21 CFR Part 820 (Medical Devices), 21 CFR Part 211 provisions for combination products, and ISO 13485 standards while building infrastructure for the new Gaithersburg facility.
Lead end-to-end product and process qualifications including facility/equipment qualification, sterilization validation, packaging development, and stability programs for two new manufacturing processes.
Drive Design Control activities including Development History Files (DHF), Device Master Records (DMR), FMEA, and Verification & Validation protocols for combination products.
Oversee Design Verification testing, biocompatibility assessments, and validation activities to establish product safety and efficacy profiles required for FDA submissions.
Build and mentor the Quality organization starting with one Principal Quality Engineer, with opportunities to expand the team as manufacturing scales.
Author and approve SOPs, specifications, quality plans, and documentation to support regulatory filings, FDA inspections, and notified body audits.
Serve as the primary quality interface with FDA, notified bodies, and regulatory agencies during inspections, audits, and post-market surveillance activities.
Manage the complete Quality Management System including Document Control, QA, Supplier Management, CAPA, Complaints, and Quality Metrics reporting to executive leadership.
Required Qualifications
10+ years of progressive Quality Management experience in FDA-regulated environments.
Deep expertise in 21 CFR Part 820 (QSR) for Medical Devices AND 21 CFR Part 211 (cGMP) for combination drug-device products—true combination product experience strongly preferred.
Proven track record in both Manufacturing/Operations and R&D/Product Development quality environments.
Hands-on experience writing, reviewing, and implementing Quality System documentation—this role requires rolling up your sleeves.
Track record successfully managing FDA inspections, notified body audits, and regulatory submissions.
Experience working in lean, fast-paced team environments where you balance multiple competing priorities and meet aggressive timelines without compromising quality.
Strong leadership skills with the ability to influence cross-functional teams and drive continuous improvement initiatives.
Comfortable being the go-to quality expert without significant day-to-day oversight—your VP trusts you to own this function.
Preferred Qualifications
Knowledge of 21 CFR Part 1271 for Human Cells, Tissues, and Cellular Tissue Products.
ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) certification.
Experience with sterilization validation and packaging qualification for implantable devices.
Background in early-stage product development and commercialization.
Compensation & Benefits
Base Salary: $160,000 - $190,000 (based on experience)
Annual Bonus: 12.5% target
Equity: Yes, included for this strategic leadership role
Comprehensive benefits package from Day 1
Work Arrangement: Hybrid (3 days per week onsite in Gaithersburg starting January 2025, with flexibility for critical project needs)
The Culture Fit
Our client values their "CRU" principles: Contagiously Confident, Ridiculously Relentless, and Unanimously United. They're looking for someone who is detail-oriented and process-driven (as any great quality professional must be) but also collaborative, pragmatic, and excited about building something meaningful. You'll need to be the "quality champion" who ensures compliance without being the person everyone avoids in the hallway.
This is a small, tight-knit team where every voice matters. If you thrive in environments where you can see the direct impact of your work and want to contribute to technology that helps breast cancer patients avoid unnecessary surgeries and complications, this is your opportunity.
Apply Now
Confidential search—your application is fully private. Apply via LinkedIn and Pave Talent will contact qualified candidates within 2-3 business days. Interviews are moving quickly, with offers expected before year-end for the right candidate.
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