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Associate Director, Clinical Quality Assurance

Company: Humacyte, Inc.
Location: Durham
Posted on: January 26, 2023

Job Description:

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 Associate Director, Clinical Quality Assurance will be responsible for leading the clinical quality function including the maintenance and oversight of GCP/GCLP/GLP/GVP activities. The primary responsibilities will be to ensure that both quality and compliance of sponsored clinical trials adhere to applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices.This position reports to Senior Vice President, QualityRemote Work Designation: Partially RemoteMajor Accountabilities:


  • Provides quality oversight of GxP (GLP/GCLP/GLP/GVP) processes and functional areas (Clinical Operations, Clinical Development, Regulatory, Nonclinical etc.) both internally and externally
  • Proactively identifies the need for and conducts various expert level audits (including internal, clinical sites, CROs, IRBs, partners, etc)
  • Provides leadership and collaboration in preparation and support of regulatory GCP/GVP inspections, prepares, and conducts Pre-Approval Inspection (PAI) activities as needed
  • Effectively and professionally collaborates with CROs and other external contractors and collaborators, managing the chain of communication related to GCP compliance
  • Drafts and revises company SOPs to assess their adequacy and compliance with industry and regulatory requirements
  • Attend and actively participates in cross-functional team meetings, providing guidance and leadership to different functional groups, based on interpretation of current regulations to ensure best practices including risk-based approaches
  • Escalates issues of critical non-compliance and/or lack of urgency in remediation with recommendations for remedy or mitigation to senior management via the Quality Board
  • Provide QA review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures and other relevant documents
  • Provide and/or assist in periodic GCP training to the internal and external staff as necessary
    Special Competencies:

    • Deep and demonstrated knowledge of Good Clinical Practices (GCP)
    • Working knowledge of "good practices" (GxP), leading to compliance with regulatory requirements
    • Experience auditing clinical study sites and CROs, experience with TMF Audits, and regulatory inspections.
    • Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically
    • Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced
    • Works as a team player, and serves as a model by participating in activities that involve cooperating with others
      General Competencies:

      • Able to communicate effectively in English, both verbally and in writing
      • Possess a positive roll-up-the-sleeves attitude and optimistic outlook
      • Represents the organization in a positive and professional manner
      • 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
      • Reports to work on time and as scheduled
        QUALIFICATIONS:

        • BS degree in relevant discipline, required
        • At least 10 years of direct GCP pharmaceutical/biotechnology experience
        • Solid understanding and application of GCP, GLP and ICH E6R2 requirements. Good working knowledge of GVP guidelines
        • Ideal candidate will have broad experience in product development, support of clinical operations, field GCP auditing and regulatory inspection support.
        • Excellent interpersonal and conflict management skills to assure effective interactions within and across departments
        • The ability to simultaneously handle multiple project issues while dealing with time demands, ability to provide a solution-based approach to emerging challenges
        • A strong team player is required with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations & business needs
          Perks:

          • 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
          • 23Days Paid Time Off (PTO)
          • 10 Company Designated Holidays + 2 Floating Holidays
          • Paid Parental Leave Policies
            **Please note, Humacyte does not provide sponsorship at this time.**

Keywords: Humacyte, Inc., Durham , Associate Director, Clinical Quality Assurance, Executive , Durham, North Carolina

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