Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
The Senior Director of Information Technology will be responsible for overseeing and managing the Information Technology function and ensuring that our company’s technology is meeting its goals and objectives efficiently and reliably. This includes both general business, desktop and hardware support, as well as GMP commercial and manufacturing systems. They are responsible for developing the IT strategy in alignment with functional leaders and developing business cases, proposed projects, and systems requirements. This position will work closely with senior leadership, functional owners, and end users to determine the best way possible to meet the technology needs of the company. This position is responsible for the strategy, planning, design, implementation, and support of the enterprise business applications and infrastructure. The Senior Director, IT will provide strong leadership so that Humacyte can leverage our technology investments through greater efficiency and quality by using technology to drive greater effectiveness resulting in superior customer satisfaction and to achieve the key business objectives.
Remote Work Designation: Not Remote
Major Accountabilities:
• Collaborate with leadership and stakeholders to develop an Information Technology Roadmap and Application Strategy for Humacyte aligned with corporate goals.
• Represent and speak for IT by presenting, explaining, promoting, defining, and negotiating with those within and outside the organization by making clear and convincing presentations to individuals and groups; by listening effectively and clarifying information; by partnering effectively on the design of automated systems; and by facilitating an open exchange of ideas.
• Ensure regulatory compliance with SOX, CFR Part 11, GDPR, and others as required.
• Ensure IT policies, standards, and best practices are in place and regularly reviewed.
• Maintain and enhance cyber security, data integrity and backup procedures in compliance with CMMC.
• Develop, manage, and align comprehensive Information Technology and Information Systems technical documentation such as network architecture diagrams, policies, standard operating procedures, risk assessments, life cycle assessments, and IT commissioning documents and the interface with Quality Systems
• Manage report company-wide IT/IS budget. Secure capital to support IT Roadmap.
• Ensure compliance with software licensing agreements and requirements.
• Identify opportunities for employee training and skills advancement.
• Conduct regular system audits to ensure IT compliance with all regulations and requirements.
• Identify deviations and act on opportunities to improve and update software and systems.
• Identify, plan and implement systems and process improvements in a quick and efficient manner and provide visibility of implementation progress to management.
• Partner with functional business owners to schedule upgrades to remain current while balancing the impact to system availability.
• Provide IT subject matter expertise during SOX, GMP, and CMMC audits.
Special Competencies:
General Competencies:
• Able to communicate effectively in English, both verbally and in writing
• 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 collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Ensures Humacyte or other required trainings/certifications are up to date
• Represents the organization in a positive and professional manner
• Reports to work on time and as scheduled
Qualifications
Perks:
**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**