Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives.
Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.
This position will provide quality expertise to support our Quality's team for the development and commercialization of ProKidney's cellular therapeutic products in compliance with relevant US, EU and ICH requirements.
The role will support the development and continuous improvement of the GMP Deviation Management Program at ProKidney as all GMP operations develop and mature organizationally.
This position will partner with internal departments to support the Deviation Management process, assuring that each Deviation is properly identified, assessed based on risk, properly reviewed and approved by appropriate functional groups, and closed out.
Essential Duties & Responsibilities:
Supports the day-to-day management of the Regulatory Compliance department's development and management of the GMP Deviation Management Program.
Ensure compliance with all Regulatory Agency requirements (e.
g.
, FDA, EMA, MHRA, etc.
.
) are being met with regards to ProKidney's Deviation Management Program.
Develop and/or review and/or approve quality standards, policies, and procedures for all functions and departments involved in cGMP activities.
Support all the Regulatory Agency inspections at the site and the preparation of Deviations and the monitoring of the completion of assigned tasks.
Lead and drive the GMP activities, work with manufacturing Managers and supervisors to complete the Deviation's assessments and evaluations on time.
Review and approve Deviation documentation
Monitor Deviation documentation completion providing updates to management.
Report serious or repeated observations or serious compliance gaps to quality management.
Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.
Participate in quality focused teams across ProKidney's broad ecosystem of functions.
Support internal audits.
Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.
Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
Utilize knowledge to improve operational efficiency.
Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
Education And Experience
Bachelor's degree required
10+ years' relevant experience in Quality Assurance
Strong organizational, analytical, and time management skills.
Ability to work well in a team environment with a positive attitude that is willing to assist other areas of the organization.
Excellent verbal and written communication skills as well as strong focus and attention to detail.
Demonstrate ability to handle multiple tasks at one time and maintain a strong attention to detail.
Ability to perform frequent physical tasks with strength and mobility.
Flexible scheduling required.
Any equivalency combination of education, experience, and training may substitute.
ProKidney is an Equal Opportunity Employer.
All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.
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