Job Title: Senior Manager, Quality Systems - Deviation and CAPA.
Job Summary: Are you passionate about developing Deviation and CAPA policies, processes, procedures and controls? Do you have excellent leadership and mentoring skills? If you are self-motivated and technically driven, you may be the perfect candidate for this Oncology-focused company. This global, clinical-stage cell therapy company has developed tumor infiltrating lymphocytes for decades and is looking to add talented individuals to their team.
The Sr. Manager of Quality Systems - Deviation and CAPA will be responsible for:
- Oversee the day-to-day QMS responsibilities, especially Deviation and CAPA management.
- Facilitate the Deviation and CAPA needs of on-going Deviation and CAPA programs on a continuous basis, and to develop and deliver content to departmental heads and senior management.
- Ensure consistency in the quality of Deviation and CAPA programs, and initiatives launched by the department.
- Create, design, and continuously improves Deviation and CAPA execution (e.g., investigation tools, associated materials, timeliness, etc.).
- Establish metrics that measure the performance and success of ongoing Deviation and CAPA programs to identify points of improvement and develops solutions that improve the effectiveness of Deviation and CAPA programs.
- Maximize the effectiveness of the Deviation and CAPA initiatives launched in the business.
The Sr. Manager of Quality Systems - Deviation and CAPA should have the following qualifications:
- Bachelor's degree in Sciences, Engineering or any related field.
- Minimum of 8 years of progressive Quality experience in Systems, and Deviation and CAPA development in a large and complex business setting, preferably working as the Deviation and CAPA in a GMP environment in the biotech, pharmaceutical and/or cell therapy setting.
- Strong working knowledge and experience of GxP regulations, quality systems and regulatory guidance documents in US and EU.
- Understanding and experience of cell therapy processes.
- Experience in developing successful Deviation and CAPA programs that have led to employee performance improvement, ultimately with positive influence n the business's overall performance and effectiveness.
If this sounds like something that you would be a great fit for, please don't wait to apply!