Senior Clinical QA Specialist

2 weeks ago

London, United Kingdom Veeva Systems Full time

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 $2B 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**

The primary responsibility of the Senior Clinical QA Specialist is to ensure quality processes are defined, monitored, and assessed across multiple product and service lines and regulated domains (e.g., GCP, HIPAA, GDPR). This role provides GCP support for products and services within the Quality Regulatory & Compliance Function performing responsibilities in varying Services areas (e.g., review of project implementation deliverables, authoring GxP documents/records, performing document control responsibilities within Vault EDMS, promoting GCP compliance).

**What You’ll Do**
- Verifies clinical compliance to applicable policies, procedures, work instructions, and regulations
- Performs GxP/Quality review of various records, including project implementation deliverables
- Promotes GCP compliance by authoring records (e.g., project incident reports for incidents impacting a Services or Development activity)
- Performs process improvement activities and CAPA investigations
- Performs document control activities to ensure compliance with internal requirements and guidelines

**Requirements**:

- Bachelor’s degree or equivalent relevant experience
- 3+ years in a Clinical QA role in Life Sciences
- Experience with content management systems (e.g. eCMS/EDMS)
- Working knowledge of Quality Principles as manifest in ISO9001 or QSRs, GCP regulations, and guidelines
- Proven technical writing skills
- Experience with Quality Management Systems (e.g., documentation and record management, computer system validation, investigations, CAPA programs)
- Excellent interpersonal, verbal, and written communication skills
- Comfortable in a dynamic environment with mínimal direction and able to adjust workload based on changing priorities

**Nice to Have**
- Experience using or implementing Veeva Vault Cloud Platform
- Clinical auditing experience
- Implementing clinical systems for customers

**Perks & Benefits**
- Medical, dental, vision, and basic life insurance
- Flexible PTO and company paid holidays
- Retirement programs
- 1% charitable giving program

RemoteUK

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

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.

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