Summary:

The Quality & Continuous Improvement Manager is a key role at Direct Relief.  This role is responsible for developing and maintaining all aspects of the Quality Management System (QMS) that support the organization’s mission, regulatory requirements, and strategic objectives.  This role requires great attention to detail and will also support continuous improvement opportunities across the organization, including process re-design and identification of process improvements that will help with overall organization efficiency.

Key Duties and Responsibilities:

• Develop, enhance, and maintain Direct Relief’s QMS that ensure policies and procedures remain current and in compliance with regulatory agencies
• Monitor and analyze key metrics for trends indicating the effectiveness of the QMS and identify areas for improvement.
• Report on the performance of the QMS (e.g., results of quality audits, corrective actions) to management.
• Lead continuous improvement activities, including contributing to system-level procedural requirements/updates.
• Resolve discrepancies, including customer or internal complaints, in a timely manner by providing leadership to teams for corrective actions, root cause analysis, and solution implementation and documentation. Follow-up on the corrective action and preventative action to assess effectivity.
• Assist in creating and revising processes, SOPs, work instructions, and other GxP documentation.
• Participate in and/or lead risk assessments.
• Promote the use of Six Sigma tools in root cause analysis, development, and problem-solving activities.
• Support activities related to the internal audits and 3rd party audits.
• Support teams with their quality deadlines to ensure tasks are completed in a timely manner and within the timeframes documented in SOPs.
• Support activities related to supplier qualification.
• Keep up on standards, regulations/laws, issues, and news concerning quality.

 Qualifications:  

• Bachelor’s degree in business management, quality management, manufacturing, engineering, or similar
• Experience working in a warehouse or manufacturing environment.
• Highly proficient in Microsoft software tools, including Word, Excel, Vizio, and PowerPoint.
• Familiarity with Microsoft SharePoint and automation workflow tools, desired.

Physical Demands:

• Prolonged periods of sitting or standing at a desk and working on a computer. 

• Must pass (clear) toxicology screening.

Required Knowledge, Skills, and Abilities:

• Knowledge of and experience with Supply Chain Management, Warehousing, and Logistics in an FDA-regulated industry requires a sound understanding of GMP/GDP.
• Solid working experience in a position related to Quality Management Systems, including a good understanding of documentation requirements and training management in the GxP environment.
• General knowledge of quality systems, ERP systems (SAP preferred), computer-based management systems, ISO standards, and application of FDA regulations for applicable products preferred.
• Detail-oriented with the ability to take initiative and work independently.
• Excellent communication and facilitation skills

• Experience with risk assessment, corrective actions, and preventive action experience resolving customer and supplier problems and process improvement efforts.

• Demonstrated ability to work effectively with cross-functional groups and build strong relationships with internal and/or external parties.
• Ability to develop written procedures and perform technical report writing.
• Knowledge of Lean and Six Sigma principles and experience using those tools in improvement activities are preferred.