Sr. Quality Specialist

THE POSITION:

The Senior Quality Specialist supports and enhances EVERSANAs quality systems while serving as the primary point of contact for client quality matters. This role ensures timely resolution of quality issues by leading investigations driving root cause analysis and CAPA activities and coordinating cross-functional responses to audits complaints and client inquiries. The position also represents client needs internally ensuring strong communication compliance and risk-based decision-making to maintain high quality and client confidence.

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

• Providing support and assisting in the development and management of quality systems at EVERSANA
• Serve as the primary quality point of contact for assigned clients ensuring professional consistent and effective communication.
• Represent client quality needs internally and ensure appropriate prioritization and follow-through.
• Coordinate and lead the resolution of client-raised quality issues complaints and concerns.
• Facilitate investigations root cause analysis and corrective/preventive actions (CAPA) in collaboration with cross-functional teams.
• Ensure timely accurate and complaint responses to client inquiries and issue reports.
• Track comments made to clients and ensured actions are completed and documented.
• Serve as the quality contact for client audits assessments and site visits.
• Prepare quality system documentation and data requested by clients.
• Coordinate internal responses and corrective actions to client audit observations.
• Influence outcomes through expertise data and riskbased decisionmaking.
• Escalate quality risks to leadership when appropriate while maintaining client confidence.
• Demonstrate a commitment to diversity equity and inclusion through continuous development modeling inclusive behaviors and proactively managing bias. 
• All other duties as assigned

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position please contact Human Resources.

EXPECTATIONS OF THE JOB:

• Travel: Occasional travel may be required less than 20%
• Hours: 40 hours per 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.

Qualifications :

MINIMUM KNOWLEDGE SKILLS AND ABILITIES:

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

• Education: Bachelors degree
• Experience and/or Training  
  • Strong problem-solving risk assessment and impact analysis abilities.
  • Flexible and able to multitask and prioritize competing demands/workload.
  • Excellent oral and written communication skills.
• Technology/Equipment: Strong technical skills in MS Office (Outlook Word Excel PowerPoint).

PREFERRED QUALIFICATIONS:

• Education: Bachelors degree with a life sciences discipline.
• Experience and/or Training:
  • 1-3 years in the pharmaceutical/biotech/medical device industry or quality assurance in a GxP environment.

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.

Additional Information :

OUR CULTURAL BELIEFS:

Patient Minded I act with the patients best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and empower others to act now.

Grow Talent I own my development and invest in the development of others. 

Win Together I passionately connect with anyone anywhere anytime to achieve results.

Communication Matters I speak up to create transparent thoughtful and timely dialogue.

Embrace Diversity I create an environment of awareness and respect.

Always Innovate I am bold and creative in everything I do.

Our team is aware of recent fraudulent job offers in the market misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites unsolicited e-mails or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S.  Compensation will be determined based on relevant experience other job-related qualifications/skills and geographic location (to account for comparative cost of living).  More information about EVERSANAs benefits package can be found at  reserves the right to modify this base salary range and benefits at any time. 

From EVERSANAs 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 ones identity. All of our employees points of view are key to our success and inclusion is everyones responsibility.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process please contact us at .

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Remote Work :

No

Employment Type :

Full-time