Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Position Profile

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 also 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 demonstrate the ability to work in a team environment and lead other professionals and peers.

Position Background:

We are searching for a Senior Quality Specialist to join our Quality Assurance Team. The position will be responsible for designing, implementing, and managing comprehensive Product Technical Complaints (PTC) and Investigations programs to ensure the highest quality standards for our pharmaceutical products. This role requires a deep understanding of pharmaceutical manufacturing processes, root cause analysis and CAPA, regulatory requirements, and quality management systems.

Remote Work Designation: Onsite/Not Remote

Major Accountabilities:

• Program Development: Design and develop a robust PTC and Investigations program tailored to the specific needs of our pharmaceutical products. Ensure compliance with applicable regulatory requirements, including FDA regulations, cGMP guidelines, and pharmacovigilance requirements, in all aspects of complaint handling and investigation activities.
• Process Implementation: Implement standardized processes and procedures for the timely and effective handling of PTCs and Investigations from initiation to resolution.
• Complaint Handling: Perform the intake, documentation, and evaluation of product complaints, ensuring timely and accurate assessment of severity and potential impact on product quality and patient safety.
• Root Cause Analysis: Lead Investigations to identify root causes and contributing factors. Apply appropriate investigative techniques and implement corrective and preventative actions (CAPAs) to prevent recurrence.
• Investigations Review: Evaluate the adequacy, completeness, severity, and potential impact of quality events to determine whether they meet the criteria for Biologics Product Deviation Reporting (BPDR) or Health Authority (HA) notification.
• Cross-Functional Collaboration: Collaborate with cross-functional teams, including Regulatory, Medical Affairs, Clinical, Manufacturing, and MSAT to address complaints and drive continuous improvement.
• Training: Provide training and support to internal stakeholders on the PTC program and Investigations, including complaint handling procedures, documentation requirements, 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 surveillance, and annual product quality review.

Other:

• One-to-One Mentorship: Offer individual mentorship and guidance to staff members on the PTC and Investigations processes and expectations.
• Reviewing Work: Review staff member’s work, providing constructive feedback and coaching to ensure accuracy, completeness, and compliance with regulatory requirements.
• Sharing Expertise: Share expertise and industry knowledge with junior staff members, helping to build their understanding of compliance principles, regulatory expectations, and best practices in the pharmaceutical industry.

Qualifications:

• Minimum 10 years’ experience working in a cGMP regulated facility in Quality Assurance with specific experience with Pharmaceutical Product Technical Complaints (PTCs) and Investigations.
• Strong understanding of FDA regulations and cGMP guidelines.
• Excellent analytical and critical thinking skills, with the ability to assess the severity and potential impact of quality events and make informed decisions regarding BPDR and HA notification requirements.
• Detail-oriented mindset with a commitment to maintaining accuracy and compliance in all aspects of investigations and reporting activities.
• Experience as a Subject Matter Expert (SME) participating in internal and external audits
• Proven experience in project management, with a track record of successfully leading and executing projects in a regulated environment.
• Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and influence outcomes.
• Ability to work independently and prioritize workload to meet deadlines in a fast-paced environment while maintaining a high level of accuracy and quality.
• Demonstrated leadership skills and the ability to mentor and guide others.

General Competencies:

• Able to communicate effectively in English, both verbally and in writing
• Excellent communication and interpersonal skills
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• 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 environment
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Ensures Humacyte or other required trainings/certifications are up to date
• Represents the organization in a positive and professional manner
• Reports to work on time and as scheduled

Highlighted Perks & 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.**