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 IT’s 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 & end-to-end 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 end-to-end reviews of custom-developed system validation packets, communicate findings, take ownership of SOPs, templates, & process improvements, and ultimately ensures all aspects of compliance are covered

Qualifications:

• Bachelor's 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 decision-making 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 co-workers, 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 https://jobs.iqvia.com

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. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $139,100.00 - $387,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). 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.