DEPARTMENT: Quality

LOCATION: Durham, NC, Onsite/Not Remote

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com.

JOB SUMMARY:

The Senior Director, Sterility Assurance & Product Quality is a strategic and operational leader responsible for ensuring the highest standards of sterility assurance and product quality across the product lifecycle—from early development through commercial manufacturing. This role provides expert leadership in contamination control, aseptic processing, and quality oversight for ATEV products, ensuring compliance with global regulatory requirements and internal standards.

This individual will lead cross-functional teams, influence global strategy, and serve as a key subject matter expert (SME) in sterility assurance and product quality, supporting both internal operations and external manufacturing partners.

ESSENTIAL FUNCTIONS:

• Lead the development, implementation, and continuous improvement of sterility assurance programs across Humacyte.
• Own and oversee contamination control strategies, aseptic process simulations, environmental monitoring, and cleanroom qualification activities at Humacyte.
• Primary for optimization and uniformization of aseptic techniques, cleaning and disinfection programs, microbial monitoring, and justification of microbial control limits.
• Serve as SME during regulatory inspections and audits, providing technical guidance and ensuring inspection readiness.
• Drive harmonization of sterility assurance practices and ensure alignment with evolving regulatory expectations (e.g., EU Annex 1, FDA guidance).
• Lead and support investigations for microbial contamination events and help establish root causes and CAPA.
• Drive implementation of new technologies related to microbial monitoring and controls.
• Provide strategic quality input to CMC teams, supporting product development, scale-up, and technology transfer.
• Oversee quality deliverables for new product introductions, including specification development, release strategies, and regulatory submissions.
• Partner with Product Development, Manufacturing, Engineering, Regulatory Affairs, and Process Development to ensure robust product and process design.
• Build and mentor a high-performing team of sterility assurance and product quality professionals.
• Foster a culture of compliance, innovation, and continuous improvement.
• Provide technical coaching and capability development across the organization.
• Other Duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree in microbiology, life sciences, pharmacy, or engineering required.
• Minimum 12–15 years of experience in sterile pharmaceutical manufacturing, sterility assurance, quality operations and quality control.
• Proven leadership in managing global sterility assurance programs.
• Experience with regulatory inspections (FDA, EMA, etc.) and global regulatory submissions.
• Strong understanding of cGMP, ICH guidelines, and regulatory expectations for sterile and novel modalities.
• Deep technical knowledge of aseptic processing, microbiology, and contamination control.
• Strategic thinker with strong decision-making and problem-solving skills.
• Excellent communication, collaboration, and influencing skills across all levels of the organization.
• Ability to manage complexity and ambiguity in a fast-paced, global environment.
• Familiarity with quality systems, risk management tools, and data analytics.
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
• Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams.
• High degree of flexibility and adaptability.
• Represents the organization in a positive and highly professional manner.

COMPENSATION & BENEFITS HIGHLIGHTS:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3^rd party firms and/or agency recruiters. **

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.