Manager, Quality and Customer Management
Medidata: Conquering Diseases Together
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,400 customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com.
Medidata Global Compliance and Strategy’s (GCS) mission is to help its stakeholders successfully navigate and interpret the global regulatory landscape thereby enabling Medidata’s clients to maximize the potential of the Medidata Cloud unified platform. The GCS team creates meaningful customer interactions through the application of a risk-based approach to continuously improving quality within the global regulatory landscape.
To proactively engage essential stakeholders within Medidata’s ecosystem, generate value in internal business engagement and create meaningful customer interactions. The seriousness with which Medidata takes its Global Compliance and Strategy function is, we believe, a competitive advantage. We seek the right person to help us maintain and grow that advantage.
Oversight of Medidata’s Quality Management System (QMS) and Customer Relationship Management is a key component of the Global Compliance and Strategy (GCS) organization. As the Manager, Global Compliance and Strategy - Quality and Customer Management, you will be responsible for enabling and coordinating the customer focused strategic and operational components of the QMS and Medidata’s Third Party Assurance Program. Reporting directly to the VP, Global Compliance and Strategy, you will manage and lead a team of professionals and interface regularly with Medidata current and prospective customers. You will collaborate with Medidata internal customer facing business units (Sales, Legal, RFX), grow Medidata’s Unified Protection Strategy in collaboration with Information Security, Data Privacy and Cloud Operations and work closely with the Vertical Integration/Quality Processes and Regulatory functions within GCS. The position interacts with all levels of management and other personnel within Medidata, as well as with auditors and other Quality and Compliance representatives of Medidata’s clients and prospects. The ideal candidate will be based in Medidata’s Global Headquarters in New York City.
Enhance and promote Medidata’s QMS and compliance approach as a Software as a Service (SaaS) technology company providing services to regulated customers. Key audience includes current and prospective customers, customer facing internal departments.
Oversight of key QMS functional responsibilities including customer audits, customer requests for information, customer relationship management.
Interfacing with quality and regulatory professionals from clients and prospects
Oversight and Management Medidata’s Third Party Assurance Program (SOC 2+/SOC1) and Certifications. Key responsibilities include promotion and adoption of Medidata’s Third Party Assurance and working cross-functionally to ensure control objectives are appropriately designed and operating effectively.
Enhance Medidata’s Trust and Transparency resources to further shape the direction of how we support our customers and partners.
Provide leadership, direction and mentoring for the day-to-day activities of GCS - Customer Focused Operation staff.
Manage the necessary support to balance workload and complete assignments to ensure the team achieves overall customer focused mission and objectives.
Coordinate with Vertical Integration/Quality Processes, Regulatory, and Regional teams to incorporate international regulatory developments and considerations within GCS’ delivery to its stakeholders.
Your Education & Experience:
Extensive experience in clinical trial processes and technologies, including a strong working knowledge of Quality Management Systems enablement.
Strong understanding of regulations governing clinical trials including Clinical Regulations (e.g., EU Clinical Trial Directive / Regulation, FDA, etc.) and Framework guidelines including ICH Good Clinical Practices (GCP).
Inspection management experience is a strong plus.
Ability to travel expected at approximately 10%.
Bachelor's degree or equivalent years of experience; Master’s degree a plus.
Requires a minimum of 3 years of experience in Quality Management Systems processes.
Prior experience in people leadership is preferred.
Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform.
Medidata Solutions have powered over 17,000+ clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.
Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.