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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