Senior Director, Quality Assurance & Quality Control

Sr. Director/Vice President, Quality Assurance & Quality Control

Neurona Therapeutics is seeking a highly experienced and dynamic Sr. Director or Vice President of Quality to oversee and lead our GMP, GCP, and GLP QA functions. The ideal candidate will be responsible for end-to-end quality management, ensuring continuous improvement and compliance with GxP regulations, internal policies, and external standards. This role will sit on the senior leadership team and will involve presentations to the board of directors.

Position Duties And Responsibilities

• Quality Assurance Execution: Execute QA tasks independently and represent the QA department both internally and externally while managing day-to-day quality-related activities.
• Strategic Leadership: Develop and implement the vision, strategy, and budget for the quality function.
• Regulatory Compliance: Ensure quality and operational regulatory compliance; act as a subject matter expert for quality investigations, documentation systems, training programs, and internal/external audits.
• Regulatory Inspections: Lead regulatory inspections, audits, and quality assessments, ensuring readiness and compliance with FDA, EMA, and other regulatory agencies in line with relevant regulations, directives, and ICH guidelines.
• Risk Management: Drive quality risk management initiatives, identifying and mitigating potential risks to product quality, patient safety, and regulatory compliance.
• Quality Support: Provide strategic guidance and support for product quality issues, deviations, investigations as needed.
• Quality Management Reviews: Schedule and lead regular Quality Management Reviews on the status of compliance.
• GMP Support: Support internal GMP manufacturing, GMP facilities and QC testing.
• Training: Oversee GxP training programs.
• GCP and GLP Support: Ensure integrity of clinical and preclinical data. Provide QA oversight of the clinical trials.
• Quality Systems Management: Implement and maintain robust quality management systems (QMS) to ensure regulatory compliance and support organizational objectives.
• SOP and Policy Development: Develop, maintain, and update standard operating procedures (SOPs) and policies to align with regulatory requirements and company standards.
• Cross-functional Collaboration: Collaborate with cross-functional teams, including manufacturing, clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments.
• Stakeholder Relationships: Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers.
• Team Leadership: Manage and mentor a team fostering a collaborative and high-performing culture.
• Vendor Management: Lead quality initiatives and efforts as it relates to vendor management.
• Board Presentations: Participate in senior leadership discussions and present to the board of directors as needed.
• Travel: Approximately 20% travel required.
  
  

Skills, Education, And Experience Required

• Minimum of 18 years of experience, with at least 5 years in a senior leadership position.
• Current in-depth knowledge, interpretation, and implementation of GxP, United States Code of Federal Regulations, ICH Guidelines, and other local government regulatory requirements.
• Experience with complex biologics is required; experience in cell or gene therapy is highly preferred
• Familiarity with stage-appropriate r clinical development a plus.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels of the organization.
• Proven track record of successfully leading quality assurance teams and driving continuous improvement initiatives.
• Experience with QA oversight of on-premises GMP manufacturing facilities.
• Strong understanding of quality risk management principles.
• Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, achieving goals in creative and effective ways.
• Prior experience with leading stage-appropriate QA/QC for early clinical development is also highly desirable.
  
  

This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position.

If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://www.cisa.gov/be-cyber-smart/report-incident to learn how to report it.