Act as the key member of the RDS IT Compliance and Validation team and 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 and Validation account lead for sponsors or clients with responsibility to ensure technology deployment and IT process consistency across Sponsor/IQVIA partnership.
• Engage with key internal stakeholders to define the Sponsor Oversight on computerized Systems engagement plan and fulfilment strategy to meet IQVIA’s compliance commitments.
• Develop communications strategy in line with company’s strategy to engage with the key sponsors.
• Outline validation 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
• Substantial experience in healthcare, life sciences (Pharma, CROs), related product or service industry.
• Relevant 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 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
