Senior Lead, Quality Assurance Auditor
United States - NY, New York
Medidata: Powering Smarter Treatments and Healthier People
Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences, creating hope for millions of people. 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 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Known for its ground-breaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. And Medidata’s ongoing commitment to infusing the patient voice into trial designs and solutions is helping to create a better and more inclusive experience for all participants in clinical studies. Medidata is involved in nearly 40% of company-initiated trial starts globally, with studies conducted in more than 140 countries. More than 70% of novel drugs approved by the Food and Drug Administration (FDA) in 2022 were developed with Medidata software. Medidata 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 and follow us @medidata.
The Life Sciences industry is one of the most highly regulated industries, regulated to ensure the utmost patient safety, patient data security and patient privacy etc. Medidata has a leading- and cutting-edge Global Compliance and Strategy (GCS) department. Two core functions within GCS are excellence in quality management and compliance, and excellence in regulatory strategy.
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.
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 Senior Lead, Customer Assurance - GCS, you will be responsible for coordinating the customer focused strategic and operational components of the QMS in collaboration with the GCS Customer Assurance team. Reporting directly to the Senior Manager, Global Compliance and Strategy, you will interface regularly with Medidata current and prospective customers and be responsible for oversight of the customer audit function. You will collaborate with Medidata internal customer facing business units (Sales, Legal, RFX, Professional Services) to manage the coordination and execution of customer audits 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, though remote candidates will be considered.
- 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.
- Support key QMS functional responsibilities including customer audits, customer requests for information, customer relationship management.
- Manage the overall customer audit process including audit scheduling, oversight of assignment of customer audits, manage responses to customer audit observations, manage Corrective Action and Preventive Actions (CAPAs), reporting of audit trends and metrics to GCS management.
- Interfacing with quality and regulatory professionals from clients and prospects.
- Manage the necessary support to balance workload related to customer audits to ensure the GCS Customer Assurance team achieves overall customer focused mission and objectives.
- Enhance Medidata’s Trust and Transparency resources to further shape the direction of how we support our customers and partners.
- Support of key QMS functional responsibilities including internal audits, quality incidents, vendor evaluation, documentation management.
- Collaborate with GCS peers in the performance and delivery of day-to-day activities of the GCS organization.
- 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).
- Demonstrated experience as a compliance functional expert (especially with regards to clinical processes and technologies) with proven ability to present to corporate executives.
- Requires a minimum of 5 years of experience in Quality Management Systems processes.
- Requires a minimum of 3 years of experience in hosting and supporting audits (Customer, External, Internal).
- Inspection management experience required.
- Ability to travel expected at approximately 10%.
- Bachelor's degree or equivalent years of experience; Master’s degree a plus.
- Prior experience in people mentorship is preferred.
As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location.
The salary range for positions that will be physically based in the NYC Metro Area is $114,750-153,000.
The salary range for positions that will be physically based in the California Bay Area is $121,500-162,000.
The salary range for positions that will be physically based in the Boston Metro Area is $113,250-151,000.
The salary range for positions that will be physically based in Texas or Ohio is $101,250-135,000.
The salary range for positions that will be physically based in all other locations within the United States is $102,750-137,000.
Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata’s non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, dental, life and disability insurance; 401(k) matching; unlimited paid time off; and 10 paid holidays per year.