Director of Quality Operations
4 weeks ago
Immunome is a clinical-stage targeted oncology company committed to developing innovative therapies for cancer patients. We are advancing a portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of targeted cancer therapies.
Job SummaryThe Director of Quality Operations will play a pivotal role in ensuring the highest standards of quality and compliance are executed across all aspects of operations. This position collaborates with internal and external stakeholders to ensure product quality and regulatory compliance throughout all stages of the product lifecycle, from development to commercialization.
Key Responsibilities- Oversee the development and implementation of quality programs for commercial and clinical manufacturing operations.
- Ensure compliance with global regulatory standards, including FDA and EMA guidelines.
- Collaborate with executive leadership to communicate quality initiatives, issues, and resource requirements.
- Lead internal and external audits, and drive continuous improvement in quality systems.
- Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.
- Bachelor's degree in life sciences, chemistry, engineering, or related field; advanced degree (MS, PhD, MBA) preferred.
- Minimum of 15 years of experience in quality assurance, quality systems, and/or quality operations within the pharmaceutical, biotechnology, or life sciences industries.
- Minimum of 5 years of leadership experience is required.
- Proven experience in managing GMP operations, QMS, including vendor management and CMO oversight.
- Strong knowledge of FDA, EMA, ICH, and other global regulatory guidelines and their application to Quality Operations.
- Experience supporting clinical and commercial stage programs, with a strong understanding of the product lifecycle from development through to commercialization.
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary: $192,871 - $257,431
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