TransPerfect Is More Than Just a Job…
Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that. Each of our 100+ offices has its own individual identity, and each also has its own unique rewards.

Compensation Starting at: $63kBenefits: Company benefits – If applicable

Who We Are:

TransPerfect is the world's largest provider of language services and technology solutions for global business. From offices in over 100 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong. For more information, please visit our website at www.transperfect.com.

What You Will Be Doing:Ensure continued compliance and expansion of the TransPerfect's Quality Management Systems (QMS) in Computerized Systems Validation within the Trial Interactive division and consult with other TransPerfect divisions as needed.Oversee various validation areas, including Software Development Life Cycle, COTS Validation, Infrastructure Qualification, Regulatory Compliance Evaluations, Validation Package Reviews/Approvals, Operational Readiness, Periodic Reviews, and Change Control.Lead the planning, execution, and documentation of computer system validation activities according to regulatory requirements (GAMP 5, Part 11, Annex 11) by developing and maintaining validation protocols, including risk assessments, test scripts, and validation plans.Collaborate with IT, Quality Assurance, and other stakeholders to ensure alignment with project timelines and objectives.Conduct validation assessments and audits to identify and address compliance issues.Provide guidance on CSV best practices and ensure adherence to internal policies and industry standards.Provide client advisory and guidance throughout the validation process.Investigate validation-specific complaints or adverse experiences, identify root causes, and implement effective corrective and preventive actions. Provide formal Client Escalation Reports to the client.Consult or contribute to other validation projects as needed and time allowing (Integrations, Upgrades, Data Migrations, internal Division validations, Company Corporate validation).Actively maintain and improve colleagues' awareness of Client Validation processes, policies, and procedures through training and any other methods.Participate in the development of new solution client-facing validation deliverables, templates, and materials.Provide continuous process and deliverable improvement ideas to Trial Interactive QA, with an emphasis on automation.Travel up to 10% domestically and internationally as required.Complete all other tasks deemed appropriate for this role and assigned by the manager/supervisor.Who We Are Looking For:Bachelor's Degree or equivalent in a relevant field (e.g., Computer Science, Information Systems, Engineering).Minimum of 6-8 years of experience in computer system validation within the Life Sciences industryProven experience in leading validation projects and managing cross-functional teams.Familiarity with Quality Management Systems (ISO 9001) and Agile Scrum methodology.

Experience in Quality Assurance, CAPA Management, Change Control, and Deviation ManagementWork well with people from a variety of different backgrounds and culturesBuild relationships with clients and co-workersCan work independently and as part of a teamDESIRED SKILLS AND EXPERIENCE:Certification in relevant areas (e.g., CSV, GAMP 5) is a plus.Experience with validation in a Software as a Service (SaaS) environment.Familiarity with ISO 27001 or HiTrust compliance standards.Experience in overseeing and training employees on SOPs and regulatory requirementsPrevious employment in Pharmaceutical, CRO, Medical Device, or Investigative SiteAble to multitask in a fast-paced environmentIn-depth knowledge of computer system validation principles and regulatory requirements.Strong understanding of GAMP 5, Part 11, Annex 11, and other relevant industry guidelines.Excellent project management skills with the ability to lead and coordinate validation activities.Effective communication and collaboration skills, with the ability to work across multidisciplinary teams.Attention to detail and a commitment to maintaining the highest data integrity and compliance standards.Superior written and spoken communication skills in EnglishExceptional problem-solving/critical thinking skills and ability to learn new skills quicklySuperior organizational and multitasking skills to meet commitments and deadlinesWhere Your Career Is Going:

At TransPerfect, there are a lot of growth opportunities. All departments offer career growth and development that can combine your skills, interest and experience. We encourage our employees to have a continuous dialogue with management about growth opportunities throughout your tenure with the company.

End your job search and find your career at TransPerfect #careersNOTjobs.

Why TransPerfect:

For more than 25 years, we have honed a culture where all kinds of ideas are shared and new ventures are not only welcomed, but also encouraged. In this fast-paced environment, employees are intellectually stimulated so they can grow alongside the organization. From Intern to President, we believe that every single employee should have a voice and contribute to the amazing services we offer our clients.

We also offer a comprehensive benefits package including medical, dental, and vision insurance, 401k matching, membership to child-care providers, and other TransPerks. You even get your birthday off because let's face it, we're stoked that you were born.

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law

For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com.