Manager, Quality Assurance and Regulatory Compliance

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:

The purpose of this Manager, Quality Assurance and Regulatory Compliance position is to take on the responsibility of developing, implementing, and maintaining the Level 2 Quality Management System (QMS) for EVERSANA’s Patient Services business unit.  This position will be responsible for managing, growing, and developing a team of individual contributors, and will work closely with the Head of Quality to organize and execute on quality and compliance processes and activities, while strengthening a culture of continuous improvement.  An individual in this position will take on an important role in leading all external and internal audit efforts for the Service Line, including the hosting of external client audits, supporting vendor audits, as well as planning, organizing, and conducting internal audits to assess compliance with regulations, client requirements, guidelines, and 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:

• Working with the Head of Quality to continuously identify opportunities to improve operational processes, build quality-by-design processes, and assist in implementation of processes across the service line
• Ensuring that EVERSANA quality systems meet or exceed best practices and regulatory standards, and participating in development strategies and plans to maintain and improve these systems
• Fulfilling the role of facilitating external client qualification and requalification audits performed against the service line, including audit communication, scheduling, coordination, preparation, evidence gathering, interview participation, and follow-up activities
• Supporting the planning and conduct of independent internal audits to assess compliance with regulations, client requirements, guidelines, and procedures.  This includes performing internal audits as lead auditor, in addition to mentoring and training the team as future independent auditors
• Providing oversight of processes around nonconformance investigation, root cause analysis, and CAPAs, including review, approval, and closure of completed records
• Creating, reviewing, and revising Standard Operating Procedures and related QMS documents to align with best practices
• Supporting the development and management of GxP activities and quality systems for the service line
• Supporting regulatory/health authority inspections
• Overseeing and supporting the external vendor auditing program for the service line, including working with the corporate supplier auditing function as well as performing vendor audits as lead auditor when needed
• Cross-collaborate with operations, subject matter experts, and the Quality team to ensure that inspection and audit responses are completed in a timely fashion from initiation to closure
• Identifying, communicating, and analyzing changes in regulatory requirements, industry trends, and other best practices
• Closely working with other compliance and security functions to support projects to maintain and strengthen data privacy and data protection controls for the service line
• Setting clear direction, effective plans, and measurable outcomes
• Ensuring work is accomplished effectively by managing employee performance, work processes and other resources
• Developing a pipeline of excellent talent to f