Clinical Compliance Operations Specialist
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Overview
Join Veeva Systems as a Clinical Compliance Operations Specialist to facilitate GCP project audits and ensure compliance across multiple product lines. Work remotely in a mission-driven organization committed to transforming the life sciences industry. 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 (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.
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
Compensation
- •Total compensation: 60,000 - 100,000 EUR
- •The 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.
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