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Head of Quality Assurance
Durham, NC 27713 United States
Promethera Biosciences, a global innovator in cell-based medicines whose mission is to help patients overcome acute and chronic liver diseases. We are a team of international experts operating out of R&D and GMP facilities in Mont-Saint-Guibert, Belgium and Durham, NC, USA.
If you are sharing our vision of becoming the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team, consider a collaboration with our fast-growing company.
Promethera Biosciences is currently hiring an experienced Head of Quality Assurance.
In her/his function as Head of Quality Assurance, the person is responsible for the following:
Establishing a quality system and team that promotes quality at Promethera Biosciences LLC.
Champion continuous improvement efforts to establish an effective Quality Management System (QMS)
Initiate and implement quality improvement activities as appropriate to raise the performance of the company’s product line.
Educate and train employees as to their impact in the quality management system.
Establish and maintain a quality management system in accordance with FDA, Health Canada, and EU cGMP guidance covering the following responsibilities:
Authority to approve or reject all components, product containers, closures, in-process materials, packaging materials, labeling and final product.
Responsibility to oversee the review of production records for errors or noncompliance and investigation of such.
Responsibility to ensure the facilities testing and approving/rejecting components, product containers, closures, in-process materials, packaging materials, labeling and product are adequate.
Responsibility for approving or rejecting all procedures or specifications impacting the safety, quality, identity, purity and strength of the product.
Report to management, on a monthly basis, on quality issues, trends and losses.
Develop and maintain a Global Quality System.
Monitor implementation of Electronic Quality and/or Data Management Systems.
Participate in internal and external quality audits.
Support all regulatory findings.
Establish collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
B.S. in Biology or other related scientific field.
At least 10 years of relevant experience in the GMP biotech/pharmaceutical industry with proven management experience.
5 years quality assurance leadership experience in biotech or pharmaceutical industries
Working knowledge of requirements for aseptic manufacturing. Basic knowledge of cell biology.
Ability to effectively develop and lead teams and work collaboratively in matrix organizations and teams.
Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
Effective communication (verbal and written) skills required.
Problem solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required.
Experience in FDA, Health Canada and EMA compliance/quality issues
North Carolina Biotechnology Center