Be the Next Game Changer
The Senior Specialist, Quality Management, is responsible for performing business-related operations of the Global Compliance and Strategy (GCS) department. Primary job responsibilities include but are not limited to documenting a quality management system, providing backup support for client audits and providing operational support to GCS-managed programs, as applicable. The position interacts with all levels of management and other personnel within Medidata, as well as with auditors and other representatives of Medidata’s clients and prospects.
Strong familiarity, proven skills in the design and implementation, and practical experience related to life sciences regulatory landscape and associated Quality Management Systems.
Promotion and adoption of Medidata’s Third Party Assurance and working cross-functionally to ensure control objectives are appropriately designed and operating effectively.
Provide support for client audits, including:
Scheduling, preparing for, hosting, and following-up on client audits of Medidata
Coordination of audit responses and the preparation and delivery of Medidata’s audit response to external auditors
Provide operational support to GCS-managed programs, including:
Quality Incident (QI) management
Quality System Document management
Internal Quality System audit (in coordination with department-led operational self assessments)
Assist GCS management with activities related to client regulatory inspections and internal audits; and regulatory inspections of Medidata itself
Respond to requests from other departments within Medidata related to quality and regulatory information and documentation for clients
Fulfill requests from GCS management related to the department’s business operations (e.g., metrics, status updates)
Your Education & Experience:
College degree (Bachelors) or higher strongly preferred
3 to 5 years experience hosting/conducting audits and/or Quality Management Systems.
Experience with corrective and preventive action programs
Effective interpersonal and verbal/written communication skills
Experience with clinical operations preferred
Medidata requires all U.S. employees to be fully vaccinated against COVID-19 and to provide documentation of full vaccination, unless qualified for an accommodation as determined by Medidata, consistent with applicable law. Although accommodation requests will be considered (and granted where appropriate/possible), it may be determined that a candidate is unable to adequately perform the essential functions of the position without imposing an undue hardship on Medidata due to customer requirements, staffing needs, or other business reasons.
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’s solutions have powered over 14,000 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.
MEDIDATA generates the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes.