Lead Quality Assurance Expert

1 week ago

Durham, North Carolina, United States HUMACYTE GLOBAL INC Full time
Job Overview

Position Title: Senior Quality Assurance Specialist

Company Overview:

Humacyte, Inc. is pioneering a groundbreaking scientific technology platform, focusing on bioengineering innovative and universally applicable product solutions aimed at enhancing patient outcomes and revolutionizing medical practices. The organization is engaged in the development and production of acellular tissues for addressing various diseases and conditions across multiple therapeutic domains.

Role Summary:

We are seeking a Senior Quality Assurance Specialist to enhance our Quality Assurance Team. This role entails the design, execution, and oversight of comprehensive Product Technical Complaints (PTC) and Investigations programs, ensuring adherence to the highest quality standards for our pharmaceutical offerings. A profound understanding of pharmaceutical manufacturing processes, root cause analysis, CAPA, regulatory frameworks, and quality management systems is essential.

Work Environment: Onsite

Key Responsibilities:

  • Program Development: Create and refine a robust PTC and Investigations program tailored to our pharmaceutical products, ensuring compliance with relevant regulatory standards, including FDA regulations and cGMP guidelines.
  • Process Implementation: Establish standardized procedures for the efficient management of PTCs and Investigations from initiation through resolution.
  • Complaint Management: Oversee the intake, documentation, and assessment of product complaints, ensuring timely evaluation of severity and potential impact on product quality and patient safety.
  • Root Cause Analysis: Lead investigations to uncover root causes and contributing factors, applying suitable investigative techniques and implementing corrective and preventative actions (CAPAs).
  • Investigations Review: Assess the adequacy and severity of quality events to determine if they necessitate Biologics Product Deviation Reporting (BPDR) or Health Authority (HA) notifications.
  • Cross-Functional Collaboration: Work closely with teams across Regulatory, Medical Affairs, Clinical, Manufacturing, and MSAT to address complaints and foster continuous improvement.
  • Training: Provide training and support to internal stakeholders regarding the PTC program and Investigations, including complaint handling and quality expectations.
  • Quality Metrics and Reporting: Develop metrics to monitor the effectiveness of the PTC and Investigations programs, preparing regular reports for management review and regulatory submissions.

Additional Responsibilities:

  • Mentorship: Offer guidance to staff members on PTC and Investigations processes.
  • Work Review: Evaluate team members' work, providing constructive feedback to ensure compliance with regulatory standards.
  • Knowledge Sharing: Share expertise with junior staff, enhancing their understanding of compliance principles and best practices.

Qualifications:

  • At least 10 years of experience in a cGMP regulated environment, specifically in Quality Assurance related to Pharmaceutical Product Technical Complaints and Investigations.
  • In-depth knowledge of FDA regulations and cGMP guidelines.
  • Strong analytical and critical thinking abilities.
  • Detail-oriented with a commitment to accuracy and compliance.
  • Experience as a Subject Matter Expert (SME) in audits.
  • Proven project management skills in a regulated setting.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and manage multiple priorities.
  • Demonstrated leadership capabilities.

General Competencies:

  • Effective communication skills in English.
  • Strong organizational and time management abilities.
  • Flexibility and adaptability in a dynamic environment.
  • Basic proficiency in MS Office applications.
  • Commitment to professional representation of the organization.

Benefits:

  • Stock Options
  • 401k Plan with a 4% Match
  • Comprehensive Medical, Vision, and Dental Plans
  • Company Paid Disability and Life Insurance
  • Generous Paid Time Off (PTO)
  • Paid Parental Leave Policies

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