At a Glance
- Tasks: Ensure compliance in clinical projects and manage audits for quality processes.
- Company: Join Veeva Systems, a pioneering SaaS company transforming life sciences.
- Benefits: Flexible work options, competitive salary, and a commitment to employee success.
- Other info: Diverse and inclusive culture with excellent growth opportunities.
- Why this job: Make a real impact in the life sciences industry while working with innovative teams.
- Qualifications: Bachelor’s degree and 3+ years in Clinical QA; strong communication skills required.
The predicted salary is between 63000 - 77000 £ per year.
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.
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)
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.
Clinical Compliance Operations Specialist employer: Veeva Systems, Inc.
Veeva Systems, Inc. is an exceptional employer that prioritises employee growth and development, offering a dynamic work culture that fosters collaboration and innovation. With the flexibility of remote work, employees enjoy a healthy work-life balance while being part of a forward-thinking company at the forefront of life sciences technology. The commitment to meaningful partnerships and project success ensures that every team member plays a vital role in shaping the future of healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Compliance Operations Specialist
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Veeva Systems, Inc. looking for candidates who are engaged and informed.
We think you need these skills to ace Clinical Compliance Operations Specialist
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Veeva Systems, Inc.. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Veeva Systems, Inc.
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Veeva Systems, Inc.’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
