Lead Quality Assurance Expert

2 weeks 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 aimed at creating bioengineered products that are universally accessible and implantable, with the goal of enhancing patient outcomes and revolutionizing medical practices. The organization, based in Durham, NC, specializes in the development and production of acellular tissues intended for treating a variety of diseases and conditions across numerous therapeutic fields. Their innovative solutions facilitate tissue repair, reconstruction, and replacement, addressing the limitations found in current care standards. Initially focusing on human acellular vessels (HAVs), the company targets several vascular markets, including trauma care, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Additionally, Humacyte is exploring future applications in 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 be able to work autonomously as well as collaboratively within the Humacyte framework. Ideal applicants will possess strong self-motivation, excellent communication abilities, and a proven capacity to function effectively in a team setting while guiding peers and other professionals.

Role Overview:

We are in search of a Senior Quality Specialist to become a vital part of our Quality Assurance Team. 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 Arrangement: Onsite/Not Remote

Key Responsibilities:

  • Program Development: Create and implement a robust PTC and Investigations program tailored to the unique requirements of our pharmaceutical products, ensuring compliance with relevant regulatory standards, including FDA regulations, cGMP guidelines, and pharmacovigilance protocols.
  • Process Implementation: Establish standardized procedures for the efficient management of PTCs and Investigations from initiation through to 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 uncover root causes and contributing factors, applying appropriate investigative methodologies and implementing corrective and preventative actions (CAPAs) to avert recurrence.
  • Investigations Review: Assess the adequacy, completeness, severity, and potential impact of quality events to determine their eligibility for Biologics Product Deviation Reporting (BPDR) or Health Authority (HA) notification.
  • Cross-Functional Collaboration: Work alongside cross-functional teams, including 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, covering complaint handling protocols, documentation requirements, root cause analysis, CAPAs, and quality expectations.
  • Quality Metrics and Reporting: Develop and maintain metrics to track 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-on-One Mentorship: Offer individual mentorship and guidance to team members on the PTC and Investigations processes and expectations.
  • Work Review: Evaluate team members' work, providing constructive feedback and coaching to ensure compliance with regulatory standards.
  • Knowledge Sharing: Share expertise and industry insights with junior staff, aiding in their understanding of compliance principles, regulatory expectations, and best practices within the pharmaceutical sector.

Qualifications:

  • At least 10 years of experience in a cGMP regulated environment within Quality Assurance, specifically related to Pharmaceutical Product Technical Complaints (PTCs) and Investigations.
  • Strong familiarity with FDA regulations and cGMP guidelines.
  • Exceptional analytical and critical thinking capabilities, with the ability to evaluate the severity and potential impact of quality events and make informed decisions regarding BPDR and HA notification criteria.
  • Detail-oriented with a commitment to accuracy and compliance in all investigative and reporting activities.
  • Experience as a Subject Matter Expert (SME) in internal and external audits.
  • Proven project management experience, with a successful track record of leading and executing projects in a regulated environment.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and influence outcomes.
  • Ability to work independently and prioritize tasks to meet deadlines in a dynamic environment while maintaining high standards of accuracy and quality.
  • Demonstrated leadership abilities and a capacity to mentor and guide others.

General Competencies:

  • Effective communication skills in English, both verbal and written.
  • Excellent interpersonal skills.
  • Positive attitude and a proactive approach.
  • Ability to thrive in a fast-paced team environment with shifting priorities.
  • Strong organizational and time management skills.
  • High adaptability and flexibility.
  • Basic computer proficiency, including knowledge of MS Word, Excel, PowerPoint, and Outlook.
  • Willingness to work as needed to meet tight deadlines.
  • Self-motivated, organized, and a critical thinker with strong communication skills.
  • Ability to work effectively in a cross-functional team setting.
  • Adherence to company policies and procedures, including SOPs and training requirements.
  • Commitment to maintaining up-to-date training and certifications.
  • Professional representation of the organization.
  • Punctuality and reliability in attendance.

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.**

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