Manager, Quality Assurance Operations
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.
Aldeyra is seeking a Manager, Quality Assurance (QA) Operations to join our growing team. This individual will provide oversight for the quality aspects relating to drug substance, drug product, and/or finished product manufacturing, testing, labeling, packaging, and distribution performed by Aldeyra’s Contract Manufacturing Organizations (CMOs) and contract test laboratories. In this role, you will help assist in the transition of Aldeyra from a R&D company to a commercial organization as we prepare for our intended commercial launch. The Manager will also support the implementation and management of quality system activities for clinical and commercial operations and assure overall compliance of clinical and commercial GMP activities.
- Perform batch record review and disposition of product.
- Provide Quality support and oversight for resolution of deviations and non-conformances related to manufacturing and testing activities.
- Conduct final review and approval of manufacturing-related documentation (i.e., master batch records, tech transfer, qualification, and validation documentation)
- Review and approve analytical documentation, including but not limited to, test methods, specifications, protocols, and reports.
- Partner with Supply Chain to provide QA support for product launch and commercialization efforts.
- Drive and monitor Quality issues related to drug substance, drug product, and finished product operations to resolution within the company and with external parties.
- Perform audits according to the Aldeyra GMP audit program.
- Lead the implementation and revision of Quality Technical Agreements between Aldeyra and GMP/GDP vendors.
- Develop and oversee appropriate Quality metrics and reporting on the state of Aldeyra’s compliance to senior management regarding critical quality and compliance-related issues and corrective actions to mitigate risk.
- Maintain CMO site readiness for Health Authority Inspections.
- Support CMC Regulatory submissions
- BS in a scientific discipline and at least 6 years of experience in Quality Assurance.
- Prior experience working with contract manufacturing organizations is required.
- Experience with commercial drug products is required.
- Experience in auditing suppliers, CMOs, and contract test labs.
- Strong knowledge of cGMP principles.
- 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.
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