Compliance Manager

We are currently looking for Compliance Manager who will be working directly with members of Regulatory Compliance Management and other internal teams to ensure the accuracy and consistency of system software development validation deliverables.About You – experience, education, skills, and accomplishments Bachelor’s degree, preferably in life sciences.  Equivalent experience may be accepted in lieu of a degree 5-7 years current experience in a software/Computer Systems Validation (CSV) role within the pharmaceutical or life sciences industriesAt least 5-7 years current experience in creating and maintaining SOPs preferredDemonstrated above average written communication skills in the English languageProven ability to work with and direct teams to accomplish goalsMust be familiar with US and EU regulations and guidanceIt would be great if you also have: Strong interpersonal and communication skills, both verbal and writtenStrong organizational and leadership skillsGoal orientedWhat will you be doing in this role?Assists with Governing GxP Computer Systems Validation byWorking directly with members of Regulatory Compliance Management and other internal teams to ensure the accuracy and consistency of system software development validation deliverables, as well as to proactively communicate status of validation undertakings, including communication of any identified barriers to management.Assisting with authorship and conduct of other assigned pre- and/or post-review/approval activities related to computer systems Validation documentation.  This includes, but is not limited to, System Risk Assessments, 21 CFR Part 11 Assessments, Computer Validation Plans, Test Plans, Test Reports, Requirement Specifications, Release Memos and Validation Summary Reports.Supporting and/or conducting Validation efforts for all internal projects, as assigned.Fostering Validation knowledge both for development teams as well as the wider Clarivate audience.Reporting results and reviewing anomalies, as appropriate, to the Regulatory Compliance team.Ensuring a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibilityUtilizes expert knowledge in identification and management of risks pertinent to computer systems validation practices within a regulated landscape.Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practicesFacilitates the identification and development of Standard Operating Procedures (“SOP”) by:Assisting with the writing, revising, and reviewing of Validation SOPs, as assignedAssists with the management of other Quality/Regulatory Compliance initiatives and programs by:Supporting Regulatory Compliance team management with development, monitoring and management of in-scope project costs, schedules, resources, and quality/compliance standards.Assisting with the development and enhancement of quality/compliance processes to promote, facilitate and ensure compliance with all regulatory and company standards.Participating in the development and maintenance of quality systems and process improvementsInvestigating quality/compliance issues and identifying/implementing corrective and/or preventative actions, as directedSupporting the development and implementation of proper document management and change control processes relating to system development and Validation.Supporting internal and external audit activities (including, but not necessarily limited to customer and Health Authority regulatory audits).Secondary ResponsibilitiesContributes to team effort by:Exploring new opportunities to add value to organization and departmental processesHelping others to accomplish resultsPerforming other duties as assignedMaintains Professional and Technical Knowledge by:Attending and participating in applicable company-sponsored trainingAttending educational workshops and reviewing professional publicationsParticipating in professional societiesKeeping informed of changes in the regulatory environment and/or regulatory requirementsWhat product they will be developing:Our end to end SaaS ‘DST’ solution focuses on drug safety, allowing our customers to streamline their literature review process and generate a variety of time-critical reports . These systems facilitate a key process in the lifecycle of pharma products for our customers around the world.About the Team The DST is a part of the ‘Pharmacovigilance’ effort within the Life Sciences division of Clarivate. With a rooted history in the domain of Medical Literature Monitoring, we provide Literature, Technology and Services as part of an end to end workflow solution that is industry-leading.Hours of Work Fulltime in IST zone40 h/weekHybrid working modelAt Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.