Associate Director, Validation

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 Associate Director, Validation will act as a leader and be knowledgeable on all aspects of validation with responsibilities focused on Commissioning, Qualification and Validation (CQV) and Computer Systems Validation (CSV) supporting Humacyte Operations. This Associate Director, Validation will manage and oversee the validation team. The Associate Director, Validation will provide oversight, lead execution and work cross-functionally and in project teams to determine the extent of validation required for the implementation of new assets, conduct impact assessments for proposed changes to existing assets, and be responsible for the execution of Humacyte's re-qualification program.

ESSENTIAL FUNCTIONS:

• Oversee the planning, execution, and documentation of validation activities for equipment, systems, instruments, and computerized systems for GMP and GxP operations.
• Ensure all validation protocols and reports are compliant with FDA, EMA, and other relevant regulatory guidelines.
• Conduct risk assessments and develop mitigation strategies for validation projects.
• Lead and mentor the validation team, fostering a culture of excellence and continuous improvement.
• Develop and implement validation strategies and policies in alignment with regulatory requirements and company goals.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Facilities, Quality Control and Manufacturing Sciences, to ensure validation activities are integrated into the overall project plans.
• Stay current with industry trends and regulatory changes to ensure the company's validation practices remain compliant.
• Represent the company during regulatory inspections and audits, providing expertise on validation matters.
• Develop and maintain validation master plans, standard operating procedures (SOPs), and other documentation.
• Other Duties as assigned.
  
  

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree in Biochemical Engineering, Biochemistry, Microbiology or other related disciplines, required. Master’s degree preferred.
• 8 years work experience in the pharmaceutical/biotech industry.
• 4 years validation experience
• 3 years people management experience
• Strong knowledge and understanding of cGMP regulations and practices pertaining to validation principles.
• 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.