Clinical Compliance Operations Specialist

Veeva Systems, Inc.; Dublin; Hybrid; EUR 60,000 - 100,000; Full time

Job summary

Veeva Systems is seeking a Clinical Compliance Operations Specialist to manage GCP project implementation audits, ensuring internal adherence to Veeva processes and maintaining quality across product lines and regulated domains.

The role partners with global cross-functional teams to promote GCP compliance, author GxP documents, review deliverables, conduct CAPA investigations, and support supplier assessments in a fast-paced environment. Experience with ISO 9001, QSRs, and CSV is valued.

Qualifications

• 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
• Excellent written and oral communication, good decision-making and time management skills

Responsibilities

• 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 support 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

Skills

Quality Management Systems

GCP regulations

Technical writing

Communication skills

Time management

Decision-making

Education

Bachelor’s degree or equivalent

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, 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)

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.

#RemoteIreland

#LI-Associate

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 [e-mail].