Clinical Compliance Operations Specialist

Job description

Veeva 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](https://medium.com/@peter.gassner/public-benefit-corporation-pbc-486e1e9508a6) (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a [Work Anywhere](https://careers.veeva.com/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](https://www.youtube.com/watch?v=TaPSP8cCSKY&ab_channel=Forbes), 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 Do - Verify compliance to applicable policies, procedures, work instructions and regulations in GCP project implementations - Perform GxP/Quality review of various records, including project implementation deliverables - Document audit findings and supports remediation efforts to project audit observations - Promote GCP compliance by authoring records (e.g., project audit reports) - Perform process improvement activities and incident/CAPA investigations - Provide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and systems - Perform supplier assessments to ensure supplier capabilities providing products and services to a regulated industry - Execute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systems ### Requirements - Bachelor’s degree or equivalent relevant experience - 3+ years in a Clinical QA role in Life Sciences - Experience 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 guidelines - Proven technical writing skills - Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities - Excellent 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) Applications - Clinical trials IT systems auditing experience - Implementing clinical systems for customers - Understanding 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 Veeva We 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: 1. A conversation with the hiring manager 2. A practical case exercise 3. A final conversation with our group's Senior Leader. - Once all interviews are complete, the manager will be in touch with a final decision.