Senior Director, IT Validation & Compliance, Research & Development Solutions
Senior Director, IT Validation & Compliance, Research & Development Solutions
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Job Description
R&DS IT:
R&DS IT is the trusted technology partner that enables Research & Development Solutions Business and provides fit for purpose optimized technology solutions that are flexible interoperable and innovative. R&DS IT is aligned to the key pillars of R&DS Business: commit to customer success delivery with exceptional quality every time differentiate with therapeutic expertise science & technology and be the employer of choice
The Role:
This Senior Director role oversees the RDS IT Validation & Compliance team of 30 team members and plays a central leadership role in many critical areas of importance as it pertains to RDS IT systems and processes.
Essential Functions:
Defining & executing validation strategy to improve quality & compliance ensures adherence to global regulations (FDA MHRA EMA GDPR) throughout system life cycle
First line of support to customer audits & regulatory inspections
Implements controls and mitigates risks related to RDS ITs regulated computerized systems
Oversees system governance establishes policies & procedures
Manages critical IT processes (System Development Lifecycle Requirements Management System Periodic reviews)
Verifies products & processes ensures smooth business operations maintains release schedules supports computerized system validation & endtoend technology compliance
M&A IT system evaluation ensures export control compliance
Contributes to sponsor RFIs enhances operational efficiency collaborates with Strategic Engagement leads & Sponsors to fulfill system validation needs
Perform endtoend reviews of customdeveloped system validation packets communicate findings take ownership of SOPs templates & process improvements and ultimately ensures all aspects of compliance are covered
Qualifications:
Bachelors Degree Engineering or equivalent qualification required
Minimum 12 years experience in IT Validation and Compliance
Sound working knowledge of standard operating procedures (SOPs) Good Clinical Practice (GCP) Food & Drug Administration (FDA) regulations quality improvement initiatives and processes
Knowledge of National and International Regulations and Drug Development process
Expert knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations
Excellent organizational interpersonal and communication skills
Excellent judgment and decisionmaking skills
Excellent leadership and line management skills
Excellent influencing and negotiation skills
Excellent ability to work in a matrix environment
Excellent ability to establish and maintain effective working relationships with coworkers managers and clients
Fluent in English
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $139100.00 $387500.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.
Required Experience:
Exec
Employment Type
Full-Time
