Senior Director, Quality Assurance en Humacyte Inc

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, Quality Assurance (QA) is a key member of the Quality Leadership Team, responsible for providing strategic direction, oversight, and execution of the company’s Quality Management System (QMS). This role ensures compliance with global regulatory requirements (FDA, EMA, ICH, and other applicable health authorities) while fostering a culture of continuous improvement and quality excellence across the organization.
 
The Senior Director will lead QA teams supporting GxP operations (GMP, GLP, and GCP as applicable), and will serve as a strategic partner to Manufacturing, Supply Chain, Regulatory Affairs, R&D, and Commercial organizations to ensure the highest standards of product quality, patient safety, and regulatory compliance.

ESSENTIAL FUNCTIONS:

Leadership & Strategy 

• Provide vision, leadership, and mentorship to the QA organization, building high-performing teams and future leaders.
• Define and implement quality strategies aligned with corporate goals and global regulatory expectations.
• Serve as a senior advisor to executive leadership on quality, compliance, and risk management matters.
• Independently report quality metrics to executive management and lead management reviews.

Quality Systems & Compliance

• Oversee the development, implementation, and maintenance of a robust QMS, including CAPA, deviations, change control, risk management, document management, training, and audit programs.
• Ensure inspection readiness across all GxP areas and serve as the lead liaison for FDA and other regulatory inspections.
• Drive harmonization and scalability of quality systems across multiple sites and/or global operations.

Operations & Oversight

• Provide QA oversight for manufacturing (internal and external/CMO), packaging, labeling, testing, release, and distribution of clinical and commercial products.
• Ensure batch records, product disposition, and QA release decisions are compliant with regulatory filings and internal standards.
• Provides oversight to cGMP Quality Assurance department and has direct accountability of the following programs: 
  1. Product Release
  2. Deviation Oversight and CAPAs management
  3. Change Controls and the Change Review Board
  4. Packaging and Labeling
  5. Validation Master Planning: Equipment, Facility, and Computerized Systems
  6. Process Validation 
  7. Specification Management
  8. Product Complaints/Reporting
  9. Analytical data review and approval
• Oversee the supplier quality program by managing supplier qualifications, conducting audits, and overseeing ongoing performance.
• Partner with Technical Operations, Supply Chain, and R&D to ensure robust technology transfer, validation, and lifecycle management of products and processes.

Risk & Continuous Improvement

• Proactively identify, assess, and mitigate compliance and operational risks.
• Champion a culture of continuous improvement, leveraging metrics, trend analysis, and quality initiatives to drive operational excellence.
• Lead quality governance forums and contribute to corporate risk management strategies.

External Engagement

• Build and manage strong relationships with contract manufacturers, laboratories, suppliers, and regulatory authorities.
• Negotiate and oversee Quality Agreements with external partners.
• Represent the company in industry forums and ensure alignment with evolving regulatory trends.
• Other Duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree in Life Sciences, Engineering, or related field required; advanced degree (M.S., Pharm.D., Ph.D., or MBA) preferred.
• 15+ years of progressive QA/Quality Systems leadership experience in a Biotechnology-related field, including a minimum of 7 years in senior leadership roles.
• Comprehensive knowledge of global regulatory requirements (FDA, EMA, ICH, ISO, WHO) and cGxP compliance standards.
• Proven track record of leading FDA/EMA inspections with successful outcomes.
• Strong experience managing QA in a multi-site, global, or contract manufacturing environment.
• Demonstrated ability to lead cross-functional teams, influence executive decision-making, and drive organizational change.
• Exceptional communication, leadership, and strategic planning skills.

KEY COMPENCIES:

• Executive presence and ability to influence at all levels of the organization.
• Strategic mindset with hands-on operational execution capability.
• Analytical and data-driven decision making.
• Ability to thrive in a fast-paced, innovative, and highly regulated environment.
   Commitment to fostering a culture of quality, compliance, and patient-centricity.
• Excellent communication and interpersonal skills.
• Excellent organizational and time management skills with ability to set own priorities in a timely manner.
• 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.