Clinical Compliance Operations Specialist

 

 

 

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.

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

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

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)

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. 

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.