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 fill future business needs Planning, organizing, and coordinating various projects, programs, and services Demonstrating 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: Tactically managing and leading the Quality and Compliance team on day-to-day activities and maintenance of the QMS Being a mentor to the team to build and develop their skills and continue a culture of having top talent Interview, select and supervise the activities of the team staff; communicate interpret and discuss with the 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 EXPECT AT IONS OF THE JOB: Needs to be credible with both internal and external audiences and have unquestioned integrity Gives high priority to both internal and external client satisfaction Appreciates the importance of this position toward the mentorship and guidance of both staff and clients Travel : Rare/occasional travel may be required, less than 10% per year Hours : 40 hours per week, Monday - Friday, with flexibility to meet with international teams as needed 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 perform the expectations listed above successfully. Qualifications 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 8-10 years in Quality Assurance function in a regulated environment (i.e. Life Sciences, Healthcare, Pharmaceutical industries). Minimum 2 or more years in a manager level position or above. Experience and/or Training - Additional minimum requirements : Past experience hosting external audits/inspections and maintaining audit readiness; Past experience conducting internal and vendor audits as lead auditor; Past experience managing and implementing quality systems and procedures Technology/Equipment - Comfortable with Microsoft Office 365 suite. Ability to effectively work independently within a Quality Management System. Communication Skills - Possesses the ability to develop and articulate complex ideas and information that generate understanding and creates a climate that motivates and encourages others to participate. Ability to effectively interact and communicate with many different departments and stakeholders throughout various organizational levels of the company, including business operations, leadership, information technology, human resources, privacy, legal, etc. Ability to communicate and behave with a high level of professionalism and customer friendliness when interacting with external partners, clients, and vendors. Positive Attitude and Energy - Exhibits an upbeat attitude, a genuine interest in others and a sense of humor. Energizes others and heightens morale through his/her attitude. Innovator - Transforms creative ideas into original solutions that positively impact the company's performance. Highly Principled - Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior. Advanced communication skills, coordination and planning skills along with an ability to interact with a variety of audiences to build collaboration and consensus. PREFERRED QUALIFICATIONS: Education - Bachelor's Degree in life sciences discipline Experience and/or Training - Prior experience with Pharmacovigilance functions. Prior Quality experience in a call center / contact center operation. Prior knowledge of chronic care pharmacy operations and regulations, specialty pharmacy operations and/or Rare Disease Licenses/Certificates - Industry certifications including ASQ, RAPS, Six Sigma Belt,etc.; Missouri Registered Pharmacy Technician, or ability to achieve; Certified in Healthcare Privacy Compliance, or ability to achieve Technology/Equipment - Mastery of the Microsoft Office 365 suite, including expert understanding of advanced functionality within Microsoft Word, Excel, and PowerPoint. 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 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 . Follow us on LinkedIn / Twitter

Created: 2024-11-05