Director/Senior Director, Quality Assurance
Sales & Business Development, Quality Assurance
Cambridge, MA, USA
Posted on Friday, November 10, 2023
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
eGenesis is seeking an experienced Quality Assurance (QA) professional to lead the Supplier Management Quality and Risk Management programs supporting clinical operations. This is a leadership opportunity with the ability to contribute and influence in the establishment of the GMP operations at eGenesis in its transitional phase into the clinical stage. The candidate will be part of a growing Quality Organization that is working closely with the Senior Leadership Team in advancing eGenesis’ pipeline into clinical trials and, later, into commercial.
This role is responsible for ensuring compliance to GMP standards of vendors that are part of the Supplier Management Program at eGenesis as well as launching and managing the Risk Management Program for the Organization. This position will report to the VP of Quality and will support the qualification of vendors/suppliers as well as facilitating the identification, assessment, and mitigation of risks associated with eGenesis’ operations. This position will be located at eGenesis’ Headquarter Offices located in Cambridge, MA, with hybrid arrangement to be considered.
SUPPLIER QUALITY MANAGEMENT RESPONSIBILITIES
- Business owner for the Supplier Quality Management Program at eGenesis.
- Coordinating qualification activities for new vendors and annual audit schedule.
- Overseeing suppliers of raw materials, reagents, equipment, and services supporting the operations at eGenesis.
- Working with key stakeholders for the selection, qualification, and management of suppliers.
- Facilitating risk assessments for new materials or services to be introduced in support of eGenesis’ operations.
- Negotiating and maintaining Quality Agreements between eGenesis and its suppliers.
- Supporting CMC regulatory submissions, as needed.
- Defining, monitoring, and reporting quality performance metrics associated with SQM.
- Ensuring suppliers readiness for regulatory inspections and/or 3rd party audits.
- Participating in on-site audits and regulatory inspections, as needed.
- Managing the Supplier Change Notification (SCN) process and deviations, change controls, and complaints related to the product or services provided by approved suppliers.
RISK MANAGEMENT RESPONSIBILITIES
- Driving the risk management strategy at eGenesis to bring visibility across the Quality Management Systems and in partnering to better inform and enhance the quality roadmap.
- Providing guidance and expertise to establish proactive and preventive measures to further advance the overall health of the Quality Organization and the operations at eGenesis.
- Facilitating risk assessments across the Functional Areas at eGenesis and working with the respective representatives in the identification, categorization, and scoring of risks and associated mitigating actions.
- Coordinating regular risks reviews and maintaining eGenesis’ Risk Register updated and ready for inspections.
- Assessing effectiveness of mitigations as part of the regular risks review.
- Bachelor’s degree in science or relevant discipline and 10+ years of GxP experience within biotechnology, pharmaceuticals, or life sciences.
- 6+ years or supplier/vendor quality management experience in a GxP regulated environment.
- Ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures.
- Ability to negotiate and implement Quality Agreements with vendors.
- 5+ years of risk management experience in a GxP regulated environment.
- Strong comprehension of cGMP regulations and guidelines (FDA/EMA/HC, among others).
- Excellent verbal and written communication skills.
- Excellent technical writing skills.
- Experience driving continuous improvement in processes and systems and ensuring compliance.