Director, GCP QA

Aldeyra Therapeutics is a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients 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.

Position Summary:

Aldeyra is seeking a Director, Good Clinical Practice (GCP) QA to join our growing team. This individual will be responsible for managing and leading all aspects of Clinical Quality Assurance activities for Good Clinical Practice (GCP). The position is responsible for managing QA oversight of clinical programs to assure continued compliance with Good Laboratory Practice, Good Clinical Practice, and Good Pharmacovigilance standards.

Responsibilities include:

• Review GLP and GCP study protocols and reports, clinical study reports, investigator brochures, regulatory submissions, etc.
• Lead the implementation of GLP/GCP/GVP inspection readiness program, including mock inspection activities at Aldeyra, CROs, and investigator sites.
• Develop and oversee risk-based audit plans.
• Conduct audits at clinical investigator sites, Contract Research Organizations (CROs), and vendors.
• Develop, implement, and maintain GCP/GLP QA systems, risk management processes,
• and SOPs for GCP and GLP activities.

• Lead the development and delivery of GCP training.
• Partner with Clinical Development/Operations and actively participates in clinical study teams to ensure GCP compliance.

• Establish quality metrics and report on the state of GCP/GLP/GVP Quality and compliance of clinical trials to senior management.
• Evaluate and provide oversight for potential clinical quality risks as relates to ICH-GCP standards and principles, and provide mitigation strategies.

Qualifications:

• BS in a scientific discipline and at least 10 years of QA experience in clinical/nonclinical development
• Strong knowledge of GCP/GLP and GVP requirements and ICH guidelines.
• Experience working with CROs.
• Experience preparing for and participating in GCP, GVP, and GLP regulatory inspections.
• Experience conducting GCP/PV/GCLP audits is required.

• Self-motivated, and highly energetic individual that will thrive in an entrepreneurial (small-company), roll-up-your-sleeves environment and is results-oriented.
• Proactively identifies issues and identifies solutions.
• Acts with urgency and passion. Enjoys helping others.
• Exceptional interpersonal skills, with a focus on rapport-building, listening, and questioning skills.
• Excellent organizational and time management skills with a high level of attention to detail.
• Excellent oral and written communication skills for effectively interfacing with internal and external organizations. Ability to articulate and convey complex data and information concisely to key stakeholders.
• Ability to handle multiple assignments in a fast-paced environment with changing priorities.
• Ability to influence others and work independently and in a team environment.
• Leadership, negotiation, and conflict management skills.
• Experience in an environment requiring problem-solving and risk-based solutions.

 To Apply:  

Please email your cover letter and resume to info@aldeyra.com