• Job Description

  Req#: R1380896

  Manager, IT Compliance role will liaise with Regulatory, Business, IT Product teams and other stakeholders to ensure a compliant delivery of products/services within IQVIA’s RDS IT. This role will advise RDS IT’s internal technology product teams on GxP compliance, SDLC, risk-based validation processes and other regulations to ensure product compliance. Monitor the CAPAs and adherence to SDLC processes and lead small to medium projects and support audits.
  Responsibilities:
  • Provide SDLC and process guidance on technology, enhancements and upgrades available that drives delivery of compliance solutions consistent with business direction.
  • Author SOPs/Work Instructions based on technology needs, global and regional regulations etc., as identified during SDLC process assets reviews and gap analysis.
  • Perform Periodic Quality reviews. Review Validation artifacts throughout the product lifecycle.
  • Advise on the build out of GxP and or Non-GxP IT environments using a strong understanding of business core functions, regulations and compliance needs while considering customers short and long-term organizational goals.
  • Regularly assesses company’s compliance systems and identifies any potential regulatory (like Part 11 or Annex 11, SOX, and other regulations) compliance gaps. Interpret, guide, and provide training on qualifications and validation requirements in a GxP / Non-GxP environment.
  • Partner with the Business/Process Owners and IT to ensure systems meets relevant regulations (eg, 21 CFR Part 11, Annex 11), and systems are maintained in a validated state.
  • Manage changes to the compliance requirements and in-scope systems on an ongoing basis, ensuring that new requirements are translated into new operating procedures.
  • Consult and advise other teams in all matters related to CSV, regulatory and privacy requirement and any other Validation/Qualification activities and drive continuous improvement of the Quality System to meet and sustain regulatory requirements compliance.
  • Develop internal trainings and presentations on SDLC and diverse regulatory guidelines. Eg, Electronic Signatures, Security Assessment, Risk based Validation approaches, etc.
  • Support technology investments to align with IT compliance architecture and roadmap in partnership with the business.
  • Support customer audits, and internal Quality Assurance audit on multiple projects, product lines, and provide recommendations on improving Quality and Productivity.
  • Initiate and manage corrective actions resulting from audit/inspection findings or other quality events pertaining to computer systems validation (CSV) deliverables or activities and determine solutions or recommendations. Manage preventive actions with a focus on process improvements and facilitate change management.
  • Lead/Manage detailed risk assessments by analyzing processes, existing controls, reports, and data exchange, classifying, evaluating, and monitoring the company’s risk on an ongoing basis
  • Participate in compliance and GxP/CSV readiness projects and provide input into GxP system change controls.

  
  Skills/Experience
  • 7+ years’ experience in healthcare, life sciences (Pharma, CROs), related product or service industry.
  • 5+ years’ experience in implementing GxP regulated IT systems.
  • Current knowledge of industry trends and best practices- for progressive quality risk management in a regulated environment including SQA functions, software testing, and test automation.
  • Understanding of the fundamentals of GxP regulations, Validations, software development processes and procedures, including agile approach
  • Possess specific strategic and tactical approach towards implementing regulatory requirements, fit for purpose or risk-based validation approach, and required documentation.
  • Experience with, ISO and other standards bodies and international standards, FDA and EMA regulatory requirements (21 CFR part 11, GxP, etc.)
  • Strong technology orientation and knowledge of broad architecture/design options
  • Understanding of regulatory implementations across cloud-based platforms and deployments such as Salesforce, AWS, or Azure, etc.
  • High-level understanding of technology, data science and/or machine learning concepts, with the ability to convey to non-technical audiences
  • Proven track record of analyzing workflows, processes, and systems for privacy 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.
  • Strong client service orientation. Good communication skills, including the ability to liaise with people across the business.
  • Ability to prioritize and work to tight deadlines and at the same time focus on Quality.

  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

• About the company

  IMS Health and Quintiles are now IQVIA. We are committed to providing solutions that enable healthcare companies to innovate with confidence, maximize opportunities and, ultimately, drive healthcare forward. We do this via breakthroughs in insights, t...

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