THE POSITION:

The most important aspect of this position is to assist and take on responsibility of the development and management of quality systems at EVERSANA – Memphis in addition to supporting independent internal and external audits to assess compliance with regulations, guidelines, and operating procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:

• To work with the Director, Quality Assurance and Regulatory Compliance to continuously identify opportunities to improve operational processes, build in quality and assist in implementation across and within the EVERSANA – Memphis location
• Help to ensure that EVERSANA quality systems meet or exceed best practices and regulatory standards and participate in development strategies and plans to maintain and improve these systems
• Assist with the development and management of all Cold Chain GDP activities and quality systems at EVERSANA – Memphis, including conducting independent internal and external audits to assess compliance with regulations, guidelines and operating procedures
• Support compliance documentation and controls within a standard quality management system across EVERSANA – Memphis
• Support activities to evaluate regulatory compliance
• SOP writing/revision
• Assist with support for Company regulatory GDP inspections, client qualification audits and routine/ad hoc audits; conduct external qualification and ongoing audits of vendors and client partners as needed
• Ensure that inspection and audit responses are completed from initiation to closure
• Support initiation and closure of QNCRs/CAPAs

• Assist with the facilitation of the interaction of internal departments, third parties and others relative to various quality initiatives
• Help identify changes in standard procedures to reflect technological changes, regulatory trends and best practices
• Mentor Quality Associate
• Setting clear direction, effective plans and measurable outcomes
• Ensuring work is accomplished effectively by managing employee performance, work processes and other resources
• Engaging employees to maximize their discretionary effort
• Developing a pipeline of excellent talent to fill future business needs
• Plans, organizes and coordinates various projects, programs and services.
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. 
• All other duties as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

PEOPLE LEADER

People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values.  In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities:

• Responsible for and oversee their respective department.
• Interview, select and supervise the activities of the department staff; communicate interpret and discuss with team the company policies and procedures.
• Determine job objectives, work methods and performance standards; review performance relative to departmental objectives discussion appraisal with each employee and performance; authorize and communicate salary changes, promotions, transfers, discipline, and discharge and administer all other personnel actions.

EXPECTIONS OF THE JOB:

Quality Oversight of Specialty Operations (M1 Quality Lead, Controlled Substances), which includes establishing and managing quality control measures to ensure suitability of systems, vendor onboarding and oversight, process/systems validation, non-conformance investigation/CAPA, risk management:

The assignment will include reviews of Eversana’s risk management process to identify gaps and to implement improvements. The individual will facilitate/or performs:

• Quality Systems management of applicable processes (e.g. SOP development and compliance).
• Quality management oversight and issue escalation of applicable processes.
• Quality management of quality agreements, validation, and qualification.
• Review applicable verification & validation plans, testing, and test reports; identify and implement improvements in our Validation processes.
• Analyzes non-conformances, trends, and corrective/preventive actions (CAPAs) related to applicable processes to identify and implement improvement opportunities.
• Leading and/or participating in the development of the risk management process for applicable processes.
• Analyze processing errors (receiving, put-away, inventory control, picking, packing, and shipping) within applicable processes.

• Travel (25% or number of days)
• Hours (40 work week)

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

• Education: Bachelor’s Degree
• Experience and/or Training : Minimum 2+ years in Quality Assurance in GxP environment (i.e. GVP, GCP, GDP, GAP).  Experience in conducting internal and external audits.
• Licenses/Certificates: Auditor certification preferred
• Technology/Equipment: Microsoft Office Applications, Warehouse Management Applications, eQMS software

PREFERRED QUALIFICATIONS:

• Education: Bachelors’ Degree in life science discipline
• Experience and/or Training: Experience in regulated manufacturing or distribution.  Experience in designing and implementing quality systems and procedures and audit conduct/readiness for the pharmaceutical and biotechnology industries.
• Licenses/Certificates: Industry Quality Certifications (i.e. ASQ)
• Technology/Equipment (if applicable, the proficiencies required to perform the job)

PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.

All your information will be kept confidential according to EEO guidelines.

From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.

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