Director/Senior Director, Quality Assurance

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.

BASIC QUALIFICATIONS

• 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.