Quality Assurance Manager (GMP)

General Description

Morgenesis is looking to employ an experienced Quality Manager to provide and oversee the quality assurance function for the company and to lead the quality team in the evolving field of cellular therapies. Based at the _Bar- Lev WFO______ (job location), Morgenesis operates the state-of-the-art, (number of) _2_ clean room GMP cellular therapy manufacturing facility. This exciting opportunity has arisen within our management team for an individual who shares our passion for quality.

This is an exciting and challenging role, and the successful candidate will be able to demonstrate the following behavioral competencies:

• Excellent leadership with the management skills and confidence to inspire others to achieve.
• Solid organizational and planning skills with the ability to plan while delivering results at deadline.
• Emotional resilience and an ability to work under pressure with a "can do attitude".
• A determination to continually develop and improve our processes.
• Keen to learn and share knowledge with the whole team.
• Good networking skills both internally and externally.

Effective communicator with the understanding of the dynamics around relationships and a proven track record in effective relationships management.

Essential Duties

The successful candidate will:

• Maintain and continually improve Morgenesis’ Quality Management Systems (QMS) and ensure that these are fully compliant with the Israeli regulations and legislation for stem cell lines and cellular therapies. The post holder will ensure compliance with the applicable HTA regulations, and the requirements of the MHRA and FDA (equivalent to FDA in Israel – MOH).
• Develop and continually improve the awareness of the Morgenesis staff in the requirements of GMP and best practices for applying GMP to Morgenesis activities.
• Review and approve the procedures relating to all Morgenesis activities to ensure their compliance with the relevant standard/guidelines.
• Ensure that the training required within each department, as determined by department managers, is carried out and recorded.
• Develop and deliver training in all aspects of Quality Management and GMP.
• Ensure systems are in place and are followed for the reporting and investigation of quality related incidents, defective products or adverse events. These systems will identify the root cause of such incidents and generate strategies for preventative actions.
• Ensure systems are in place for the control of critical documents (e.g. SOPs, policies) and records (e.g. batch production records) to ensure they are reviewed regularly to reflect current processes and they are available at the point of use.
• Collaborate with various departments in order to facilitate clinical trials.
• Ensure Risk Management Procedures are in place and risk assessments are performed across all aspects of the GMP activities.
• Ensure that equipment and processes used in the manufacture, storage and distribution of products are subject to effective validation and that documentation used in validations are approved by the post holder.
• Ensure that effective change control procedures are in place for changes to the manufacturing process, GMP activities and other areas of the company as applicable.
• Lead on a program for auditing of all internal Morgenesis operations and supplier of raw materials and services used in the processes of the Company.
• Participate in Morgenesis management processes by membership of key management teams to ensure strategic and developmental decision can be made on the basis of informed advice on issues of quality and regulatory matters.

Provide regular reports to Morgenesis’ management team, identifying deficiencies in the QMS and advising on the necessary corrective action.

 Requirements

• An honors degree in a relevant life science or equivalent qualification.
• Experience in the successful management of a GMP Quality Assurance department within the production of cellular therapies or a related field.
• Must have a good working knowledge of GMP clean rooms operating at a Grade A/B level.
• A good scientific knowledge of cell therapies is desirable, but an understanding of biological systems is essential.
• Excellent report writing skills with the ability to simplify and clearly present complex information.
• Excellent administration and office management skills.
• Excellent data recording and record keeping skills.
• Experience in using Q-Pulse Document Management system would be highly desirable.

Purpose

As the Morgenesis Quality Assurance Manager the primary function is to develop, manage, and coordinate the Quality Assurance requirements of the company. This requires maintenance of the Quality Management System which ensures compliance with the necessary legislation.

The principal objective is to ensure that stem cell lines and cellular therapies produced by Morgenesis fully comply with the requirements of Good Manufacturing Practice (GMP).