Senior Manager, Quality Operations & QMS at 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:

As the Senior Manager, Quality Operations and Quality Management Systems, you will play a pivotal role in ensuring quality, safety, and compliance at Humacyte. You will lead teams responsible for maintaining and managing quality management systems and managing shop floor quality program that meet industry regulations and standards. The Senior manager implements and oversees quality on the production floor, focusing on preventing defects, ensuring compliance with standards, and driving continuous improvement.  Your expertise will help drive the company's commitment to delivering safe and effective products to our customers.  

ESSENTIAL FUNCTIONS:

Quality Management Systems (QMS):

• Maintain and manage a comprehensive QMS to ensure compliance with applicable regulations (e.g., FDA, EMA).
• Drive continuous improvement in the QMS to meet business needs while maintaining compliance.

Quality Operations

• Provide direct quality oversight and leadership on the production floor, ensuring adherence to quality standards and procedures.
• Work closely with operations, engineering, and other departments to address quality concerns and achieve departmental objectives.
• Support investigating quality issues, conducting root cause analysis, and implementing corrective actions to prevent recurrence.
  • Supervise, train, and motivate quality operations personnel and production staff on quality expectations and practices.

Regulatory Compliance:

• Stay current with all relevant industry regulations and standards.
• Coordinate regulatory audits and inspections, as required.

Document Management:

• Oversee site document administration activities.
• Oversee the creation and maintenance of quality systems standard operating procedures (SOPs), work instructions, forms, etc.
• Ensure that documentation is accurate, up-to-date, and readily accessible.
• Manage document issuance, reconciliation, archival, and retention, including oversight of the QA Records Room and offsite storage.

Training Program:

• Oversee site Training Program.
• Train and develop the quality systems team to ensure their competence and compliance with established procedures and best practices.
• Foster a culture of continuous improvement and quality awareness.

Risk Management:

• Implement risk management strategies to identify, assess, and mitigate potential quality-related risks.
• Ensure proactive risk assessment throughout the product lifecycle.

Metrics and Reporting:

• Establish key performance indicators (KPIs) and regularly report on the performance and status of the QMS.
• Provide management with insights and recommendations for improvement.
• Support Quality Management Review process at Humacyte.

Inspection Management:

• Establish and oversee logistics for managing inspections including the backroom, SMEs, documents, reports, etc.
• Manage inspection training.

GENERAL COMPENCIES:

• Demonstrated background in support of cGMP Quality Management systems
• Demonstrated background in quality operations and ability to lead on operations floor
• Excellent written and oral communication skills.
• Experience in evaluating technical quality problems and providing recommendations for corrective actions
• Routinely communicate findings and information to peers and other team members; transparency and knowledge sharing is expected and practiced
• Understanding of Quality Systems, Documentation and Records Control, Training, Deviations, CAPAs, and Change Control
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Strong communication (verbal and written) skills with the ability to motivate others
• Basic computer skills required: knowledge of MS Word, Excel, PowerPoint, Outlook, MasterControl™ and other cGMP Quality System applications
• Demonstrate strong critical thinking and organizational skills
• Strong problem solving and analytical skills
• Effectively communicates high level training concepts to leadership
• Capable of writing management level reports and summaries
• Clearly communicates issues with co-workers and supervision in a timely manner

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree required in science or engineering
• Minimum of 10 years of experience in Quality Systems and Quality Operations, with at least 5 years in a supervisory or managerial role
• Strong understanding of cGMP and data integrity.
• Demonstrated ability to work in a cross functional team
• Demonstrated experience with project management and continuous improvement.
• Firm understanding of Quality Management Systems and Quality Operations
• Certifications in quality management (e.g., ASQ, Six Sigma) are a plus
• Experience with Inspection methodologies
• Excellent communication and interpersonal skills.
• 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.
• Excellent organizational and time management skills with ability to set own priorities in a timely manner.
• High degree of flexibility and adaptability. 
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
• 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.