Location: Remote, Ireland | Type: Remote | Country: IEVeeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role As a Clinical Compliance Operations Specialist, you will facilitate and manage GCP project implementation audits ensuring internal adherence to Veeva processes. The Clinical Compliance Operations Specialist will ensure quality processes are defined, followed, and maintained across multiple product and service lines and regulated domains (e.g., GCP, HIPAA, CSV). This role will work closely with cross-functional global teams to provide GCP support for Veeva products in varying Services areas by promoting GCP compliance, authoring GxP documents and records, reviewing project implementation deliverables, incident management review, and performing occasional supplier assessments. What You'll DoVerify compliance to applicable policies, procedures, work instructions and regulations in GCP project implementationsPerform GxP/Quality review of various records, including project implementation deliverablesDocument audit findings and supports remediation efforts to project audit observationsPromote GCP compliance by authoring records (e.g., project audit reports)Perform process improvement activities and incident/CAPA investigationsProvide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and systemsPerform supplier assessments to ensure supplier capabilities providing products and services to a regulated industryExecute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systemsRequirementsBachelor’s degree or equivalent relevant experience3+ years in a Clinical QA role in Life SciencesExperience with Quality Management Systems (e.g., documentation and record management, computer system validation, investigations, CAPA programs)Working knowledge of Quality Principles as manifest in ISO 9001 or QSRs, GCP regulations and guidelinesProven technical writing skillsComfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing prioritiesExcellent written and oral communication skills, good decision-making skills and time management skills**Nice to Have**Experience using or implementing Veeva Development Cloud (Clinical Data) ApplicationsClinical trials IT systems auditing experienceImplementing clinical systems for customersUnderstanding of Agile methodology and software development cycle (SDLC) and computer systems validation (CSV)Quality Auditor Certification (ASQ CQA or ISO 13485 Auditing Certificate)Interviewing with VeevaWe value your time and believe in a transparent hiring process. Here is the process you can expect.Follow the application process and submit your resume.Within 3 days, you will receive a link to a personality assessment administered by a third party.Once you complete the assessment, our team will review your full application package and follow up via email with our decision.If moving to the interview stage, the process is as follows:A conversation with the hiring managerA practical case exerciseA final conversation with our group's Senior Leader.Once all interviews are complete, the manager will be in touch with a final decision.CompensationTotal compensation: 60,000 - 100,000 EURThe total compensation range listed here has been provided to comply with local regulations and represents a potential total compensation range for this role. Please note that actual total compensation may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position's total compensation may be composed of other types of compensation, such as variable bonus and/or stock bonus.RemoteIreland
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
As an equal opportunity employer, Veeva is committed to fostering a culture of inclusion and growing a diverse workforce. Diversity makes us stronger. It comes in many forms. Gender, race, ethnicity, religion, politics, sexual orientation, age, disability and life experience shape us all into unique individuals. We value people for the individuals they are and the contributions they can bring to our teams.
If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent\_accommodations@veeva.com.
16 days ago