Senior Quality Assurance Specialist

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.

J OB SUMMARY :

We are searching for a Senior Quality Assurance Specialist to join our QA Team. This individual will be responsible for designing, implementing, and managing comprehensive Product Technical Complaints (PTC) and Investigations programs to ensure the highest quality standards for our pharmaceutical products. This role requires a deep understanding of pharmaceutical manufacturing processes, root cause analysis and CAPA, regulatory requirements, and quality management systems.

ESSENTIAL FUNCTIONS :

• Program Development : Design and develop a robust PTC and Investigations program tailored to the specific needs of our pharmaceutical products. Ensure compliance with applicable regulatory requirements, including FDA regulations, cGMP guidelines, and pharmacovigilance requirements, in all aspects of complaint handling and investigation activities.
• Process Implementation : Implement standardized processes and procedures for the timely and effective handling of PTCs and Investigations from initiation to resolution.
• Complaint Handling : Perform the intake, documentation, and evaluation of product complaints, ensuring timely and accurate assessment of severity and potential impact on product quality and patient safety.
• Root Cause Analysis : Lead Investigations to identify root causes and contributing factors. Apply appropriate investigative techniques and implement corrective and preventative actions (CAPAs) to prevent recurrence.
• Investigations Review : Evaluate the adequacy, completeness, severity, and potential impact of quality events to determine whether they meet the criteria for Biologics Product Deviation Reporting (BPDR) or Health Authority (HA) notification.
• Cross-Functional Collaboration : Collaborate with cross-functional teams, including Regulatory, Medical Affairs, Clinical, Manufacturing, and MSAT to address complaints and drive continuous improvement.
• Training : Provide training and support to internal stakeholders on the PTC program and Investigations, including complaint handling procedures, documentation requirements, root cause analysis, CAPAs, and quality expectations.
• Quality Metrics and Reporting : Develop and maintain metrics to monitor the performance of the PTC and Investigations programs, including complaint trends, timelines, and CAPA effectiveness. Prepare regular reports for management review, regulatory submissions and surveillance, and annual product quality review.
• One-to-One Mentorship : Offer individual mentorship and guidance to staff members on the PTC and Investigations processes and expectations.
• Reviewing Work : Review staff member's work, providing constructive feedback and coaching to ensure accuracy, completeness, and compliance with regulatory requirements.
• Sharing Expertise : Share expertise and industry knowledge with junior staff members, helping to build their understanding of compliance principles, regulatory expectations, and best practices in the pharmaceutical industry.
• Other Duties as assigned.

EXPERIENCE & QUALIFICATIONS :

COMPENSATION & BENEFITS HIGHLIGHTS :

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.