Company Description

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs.  We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.  

Job Description

THE POSITION:

We are seeking a highly skilled and detail-oriented Quality System Manager to oversee and enhance our Quality Management Systems (QMS) to ensure compliance with regulatory requirements and the industry’s best practices. This individual will be responsible for the development, implementation, and continuous improvement of quality processes, ensuring the highest standards of warehouse and distribution activities.

As the Quality System Manager, you will play a key role in maintaining compliance with regulatory agencies, such as the FDA, DEA, National Association of Boards of Pharmacy (NABP) and other relevant authorities, while leading cross-functional teams to support and sustain a robust quality culture within the organization.

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

Quality System Oversight:Develop, implement, and maintain the company’s Quality Management System (QMS) in compliance with warehouse and distribution regulations, standards and best practices/trends.Lead the development and revision of standard operating procedures (SOPs) and work instructions for associated warehouse and distribution processes.Regulatory Compliance:Ability to monitor and interpret regulatory requirements to ensure that quality systems and practices remain compliant.Coordinate audits (internal and external), including supplier management.Prepare, schedule and support regulatory agency inspections (e.g., FDA, DEA and NABP) and customer audits, including those by regulatory agencies, ensuring readiness and compliance.Quality Metrics & Reporting:Establish and track key performance indicators (KPIs) for quality system performance, ensuring continuous improvement.Prepare regular reports on quality system performance, audit outcomes and response status, QNCR closure status, corrective actions, and management review status for senior management and other stakeholders.Continuous Improvement:Drive the implementation of continuous improvement initiatives within the Quality Management System, leveraging tools like CAPA (Corrective and Preventive Actions), risk assessments, and root cause analysis.Facilitate risk management activities and help to ensure that quality risks are assessed and mitigated.Training & Development:Lead and organize Learning Management System (LMS) training sessions for employees on quality systems, regulatory compliance, and best practices to ensure understanding and adherence to required standards.Supervise, provide guidance and mentor direct reports.Cross-functional Collaboration:Collaborate with other departments, including Operations, Continuous Improvement, IT, Serialization, and Supply Chain, to ensure quality systems are integrated across the organization.Act as a subject matter expert on quality system issues, providing support and guidance to various teams and departments.Document Control:Oversee document management and control systems, ensuring that all quality documents are appropriately maintained, reviewed, and updated.Ensure proper document control and compliance with internal and external requirements.Root Cause Analysis & CAPA:Lead the investigation of non-conformances, deviations, and complaints, ensuring timely resolution and implementation of corrective and preventive actions.Ensure that CAPA processes are effective and contribute to systemic improvements in warehouse and distribution activities.Other duties as assigned

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

EXPECTATIONS OF THE JOB:

Travel – 10% or less; based on supplier management audit schedule needs.Hours – Full time role, 40 hours per week; additional time maybe required to complete tasks.

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: A college degree or equivalent experience; Life Sciences, Chemistry, Engineering, or related field.Experience and/or Training: Minimum 5 years quality support in warehouse, distribution, laboratory or manufacturing. Strong oral and written communication skills.Licenses/Certificates: N/ATechnology/Equipment: Strong knowledge and use of Microsoft Office Applications (Word, Excel, and PowerPoint, etc.)

PREFERRED QUALIFICATIONS:

Education: A college degree or equivalent experience.Experience and/or Training: 7+ years in Quality Assurance.Licenses/Certificates: Industry Quality Certifications (i.e., ASQ)Technology/Equipment: Microsoft Office Applications, Warehouse Management Applications, eQMS software

PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:

The physical and mental requirements along with the work environment characteristics described here are representative of those 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 listen; 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.

#INC

Additional Information

OUR CULTURAL BELIEFS:

Patient Minded I act with the patient’s 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.

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.

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 [email protected].

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