Director, IT Compliance (Sponsor Engagement)

Published date Posted on Indeed on Jun 21, 2022 (8 d ago)

Dir, IT Compliance (Sponsor Engagement) will be part of the RDS IT Privacy and Compliance team. Key IT compliance point of contact between IQVIA’s sponsors or clients, internal IT product teams and enterprise quality assurance teams. Be a critical internal stakeholder to provide compliance insight, perspective, and input into the Sponsor Engagement Plans and fulfilment strategy to meet the IQVIA’s compliance commitments. Work with product teams to advise and guide on IT design and implementation of enterprise and local data GxP regulated systems.


Responsibilities:

  • Act as an IT Compliance account lead for sponsors or clients with responsibility to ensure technology deployment and IT process consistency across Sponsor/IQVIA partnership.
  • Identify and engage with key internal stakeholders to define the Sponsor Engagement Plan and fulfilment strategy to meet the IQVIA’s compliance commitments.
  • Develop communications strategy in line with company’s strategy to engage with the key sponsors.
  • Outline a methodology and approach for how the expectations, decisions, risk/issues, and project progress information will be communicated to the sponsor.
  • Define and advise product teams on the regulatory requirements and risks within the product life cycle based upon regulatory guidance’s and global regulations.
  • Participate in conduct and review of system compliance assessments, categorization, and regulatory impact assessments, and computer system validations for developing technologies.
  • Support regulatory inspections and customer audits or qualifications consistent with corporate policy and position as determined by IQVIA’s Quality Management System.
  • Represent IQVIA Quality Management in sponsor meetings and keep them informed on IQVIA’s vision, goals, and products.
  • Effectively communicate the sponsor needs to the IT team and follow through for successful closure.
  • Serve as an escalation point for any sponsor reported IT compliance and quality issues. Assist in the development of Compliance KPIs to track the effectiveness of partnership.
  • Drive teams to efficiently gather the computerised system validation and associated materials. Assess the review of requested deliverables for accuracy and completeness.
  • Partner with QA to ensure IQVIA vendor process and deliverable compliance. Recommend actions to align with Sponsor requests.
  • Foster system lifecycle and validation process alignment with various internal product teams to comply with the product quality.

Skills/Experience

  • 15+ years’ experience in healthcare, life sciences (Pharma, CROs), related product or service industry.
  • 5+ years’ experience working with clients or sponsors representing IT process, computer systems validations during qualifications or audits.
  • Current knowledge of industry trends and best practices for progressive quality risk management in a regulated environment including SQA functions, software testing, test automation and Privacy by Design principals.
  • Strong client service orientation. Good communication skills, including the ability to liaise with people across the business.
  • Possess specific strategic and tactical approach towards fulfilment of sponsor needs relevant to IT compliance areas (eg, computerized systems validations, audit trail reviews, etc.)
  • Sufficient knowledge and experience in managing sponsor expectations, required documentation, and other deliverables in a timely manner.
  • Experience with regulations (e.g., FDA, MHRA, EMA, 21 CFR part 11, GxP, etc.
  • Proven track record of analyzing workflows, processes, and systems for validation gaps, interpret and apply pragmatic solutions, and effectively documenting them.
    • Must have good people skills and the ability to interact and communicate effectively, orally and in writing, across all levels. Ability to work well in both a team and individually.
  • Excellent writing, organizational and problem-solving skills.
  • Ability to prioritize and work to tight deadlines and manage own caseload.
  • Education
  • Minimum Bachelor’s degree in Computer Sciences, Life Sciences, Information Systems, or relevant field. Master’s degree in relevant field is preferred.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status


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