Aldeyra Therapeutics is a biotechnology company devoted to developing and commercializing next-generation medicines to improve patients’ lives with immune-mediated diseases. Aldeyra’s lead investigational drug product candidates are potential first-in-class treatments in development for dry eye disease, allergic conjunctivitis, and proliferative vitreoretinopathy. The company is also developing other product candidates for retinal and systemic inflammatory diseases.
The Head of QA role is a key strategic leadership position within the Aldeyra organization. The primary responsibility will include formulating and implementing the next evolution of quality within the company. The Head of QA will build, lead and evolve the quality function commensurate with the company stage and ensure global regulatory, industry, and corporate standards are met.
Additionally, the selected candidate will develop and maintain an industry-standard corporate quality structure, quality management system, and associated quality processes and procedures to support all GXP operations. Ensure compliant drug product development and manufacturing, clinical trial and non-clinical study implementation, global regulatory communication, and clinical and commercial distribution.
• Work closely with the Leadership Team to define and establish an integrated Quality System for all GxP (GMPs, GCPs, GLPs, GVPs) areas from R&D through Licensure and Commercialization that will be a benchmark for the industry.
• Establish, develop and implement Aldeyra’s enterprise-wide Quality standards, practices, and SOPs. Responsible for recommending, monitoring, and engaging in corrective actions for all identified deviations, along with responsibility for coordinating all activities related to training and education.
• Lead a team of quality professionals and direct supervision of QA employees/contractors, including objective setting, performance management, coaching, training/mentoring, development, and recruiting.
• Ensure the company has quality systems to ensure “inspection readiness” and successful mock inspections and subsequent PAI.
• Develop, implement, and maintain all GxP activities in R&D in alignment with business objectives and regulatory requirements across all subsidiary programs and functional activities.
• Set strategy in partnership with the Senior Leadership, and assure appropriate management oversight of Quality Performance.
• Leverage enterprise-wide expertise in GxPs to oversee all the research and development activities and ensure that they are conducted within the applicable regulatory requirements, guidelines, and laws.
• Devise, execute and maintain an “Inspection Readiness” program that prepares for US and global inspections by any regulatory authority and interface with regulators.
• Recommend, monitor, and engage in corrective actions for all identified deviations from GxPs and SOPs, along with responsibility for coordinating all activities related to training and education in GxPs.
• Minimum of 15+ years of professional quality experience across multiple GxPs within a high-performance drug development environment, ideally with a broad emphasis across corporate quality and GxP implementation. A demonstrated track record of progressively responsible leadership roles.
• Broad and deep regulatory knowledge and fluent in the fundamental principles and practices of drug development and possess the requisite understanding and track record of demonstrating the benefits of quality compliance to corporate affairs, research and development, clinical and commercial manufacturing, clinical trial contracting/recruiting, medical affairs, medical safety, and regulatory affairs.
• A functional grounding in both the US and international regulations and guidance is required, along with the experience of previously building out a global and progressive quality assurance organization includes recruitment, objective setting, performance management, coaching, training, and development.
• Proven ability in developing and advance progressive quality operational models, systems, and frameworks, enabling effectiveness, sustainability, flexibility, and adaptability in a dynamic and evolving business model.
• Experience in ensuring that Standard Operating Procedures (SOPs) are by GxP guidelines and meet local regulatory requirements.
• Prior responsibility for the successful preparation and oversight of an “Inspection Ready” organization by any US or international regulatory authority and experience interacting face-to-face with regulators. Successfully Leading a company through a PAI. In addition, she/he will have auditing experience across the full range of CMC & clinical audit environments such as CROs/CMOs, investigator sites, protocols, clinical study reports, systems, and submissions.
• Current knowledge of industry trends and best practices for progressive quality management within a regulated environment
• The candidate must possess excellent written and verbal communication and can facilitate/articulate recommendations and critical decision points to senior management; demonstrated experience reducing complex subjects to key points; ability to develop a strong network across the company.
• The candidate must have the ability to develop new business relationships and nurture partnerships with internal and external stakeholders. Additionally, have the ability to provide cross-functional team leadership to maintain alignment and to set and meet collective operational goals.
Please email your cover letter and resume to firstname.lastname@example.org or to our corporate address:
Aldeyra Therapeutics, Inc.
Attention: Human Resources, 131 Hartwell Avenue, Suite 320, Lexington, MA 02421
To apply for this job please visit aldeyra.com.