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Lead Quality Assurance Analyst

2 months ago

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

Senior Quality Assurance Specialist

Position Summary

Humacyte Global Inc. is pioneering a groundbreaking scientific technology platform, focusing on bioengineering universally implantable product solutions aimed at enhancing patient outcomes and revolutionizing medical practices. The organization is engaged in the development and production of acellular tissues intended for treating various diseases and conditions across multiple therapeutic domains. Our innovative technology facilitates tissue repair, reconstruction, and replacement, addressing the limitations of current care standards. Initially, we are concentrating on a portfolio of human acellular vessels (HAVs) targeting diverse vascular markets, including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Furthermore, Humacyte is dedicated to exploring future markets such as pediatric heart surgery, cellular therapy delivery, and various novel cell and tissue systems.

We are seeking qualified professionals to enhance our growing team. Candidates should exhibit a high degree of self-motivation, effective communication skills, and the capability to work collaboratively and independently within the Humacyte framework.

Role Overview:

We are in search of a Senior Quality Specialist to join our Quality Assurance Division. This role will entail the design, implementation, and management 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 requirements, and quality management systems is essential.

Work Designation: Onsite/Not Remote

Key Responsibilities:

  • Program Development: Craft and establish a robust PTC and Investigations program tailored to the specific requirements of our pharmaceutical products. Ensure compliance with relevant regulatory standards, including FDA regulations, cGMP guidelines, and pharmacovigilance requirements in all aspects of complaint management and investigation.
  • Process Implementation: Execute standardized procedures for the efficient handling of PTCs and Investigations from initiation through resolution.
  • Complaint Management: Oversee the intake, documentation, and assessment of product complaints, ensuring timely and precise evaluation of severity and potential implications for product quality and patient safety.
  • Root Cause Analysis: Lead investigations to ascertain root causes and contributing factors. Employ suitable investigative techniques and implement corrective and preventative actions (CAPAs) to avert recurrence.
  • Investigations Review: Assess the adequacy, completeness, severity, and potential impact of quality events to determine if they meet the criteria for Biologics Product Deviation Reporting (BPDR) or Health Authority (HA) notification.
  • Cross-Functional Collaboration: Work in partnership with cross-functional teams, including Regulatory, Medical Affairs, Clinical, Manufacturing, and MSAT, to address complaints and promote continuous improvement.
  • Training: Provide training and support to internal stakeholders regarding the PTC program and Investigations, covering complaint handling procedures, documentation standards, root cause analysis, CAPAs, and quality expectations.
  • Quality Metrics and Reporting: Develop and maintain metrics to monitor the performance of the PTC and Investigations programs, including complaint trends, timelines, and CAPA effectiveness. Prepare regular reports for management review, regulatory submissions, and annual product quality assessments.

Additional Responsibilities:

  • One-to-One Mentorship: Offer individual mentorship and guidance to team members on the PTC and Investigations processes and expectations.
  • Reviewing Work: Evaluate team members' work, providing constructive feedback and coaching to ensure accuracy, completeness, and compliance with regulatory standards.
  • Sharing Expertise: Impart expertise and industry knowledge to junior staff, aiding in their understanding of compliance principles, regulatory expectations, and best practices within the pharmaceutical sector.

Qualifications:

  • Minimum of 10 years of experience in a cGMP regulated environment within Quality Assurance, with specific expertise in Pharmaceutical Product Technical Complaints (PTCs) and Investigations.
  • Strong knowledge of FDA regulations and cGMP guidelines.
  • Exceptional analytical and critical thinking abilities, capable of assessing the severity and potential impact of quality events and making informed decisions regarding BPDR and HA notification requirements.
  • Detail-oriented approach with a commitment to maintaining accuracy and compliance in all facets of investigations and reporting.
  • Experience as a Subject Matter Expert (SME) participating in internal and external audits.
  • Proven project management experience, with a history of successfully leading and executing projects in a regulated setting.
  • Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and influence outcomes.
  • Ability to work independently and prioritize tasks to meet deadlines in a dynamic environment while maintaining high accuracy and quality standards.
  • Demonstrated leadership capabilities and the ability to mentor and guide others.

General Competencies:

  • Proficient in English communication, both verbal and written.
  • Excellent communication and interpersonal skills.
  • Possess a proactive attitude and an optimistic outlook.
  • Strong ability to thrive in a fast-paced team environment with shifting priorities, collaborating effectively with others.
  • Outstanding organizational and time management skills, with the ability to set personal priorities efficiently.
  • High degree of flexibility and adaptability.
  • Basic computer skills required, including knowledge of MS Word, Excel, PowerPoint, and Outlook.
  • Must be able to work as needed to meet tight deadlines and during peak periods.
  • Self-motivated and organized critical thinker with strong interpersonal and business communication skills.
  • Demonstrated ability to function effectively in a cross-functional team environment.
  • Adheres to company and facility-specific policies and procedures, including SOP, training, and meeting requirements.
  • Ensures that Humacyte or other required trainings/certifications are current.
  • Represents the organization positively and professionally.
  • Reports to work punctually and as scheduled.

Highlighted Benefits:

  • 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 sponsorship at this time and does not accept unsolicited resumes from recruiters.**