ZenQMS is on a mission to elevate the role of quality in the Life Sciences and support quality professionals with digital process management. Our innovative, easy-to-use platform supports regulated companies all around the world to manage their critical-to-quality activities. Our team and broader community are organized around our core values: be kind, always be improving, be part of the community, and keep it simple.
The Compliance and Audit Specialist (CAS) is responsible for ensuring that ZenQMS is in compliance with Standard Operating Procedures (SOPs) and any other relevant regulations and standards. The CAS will perform internal audits and host client audits, provide recommendations for process improvement, and help implement a plan to address changes. The CAS will maintain current records, proactively prepare for client audits, and also work closely with clients in reviewing compliance procedures and processes. The successful CAS will be someone who will facilitate regulatory compliance to help ZenQMS maintain an excellent reputation.
· Support Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR) implementation .
· Support ISO 9001:2015 and 27001:2013 implementation.
· Support System and Organization Controls (SOC) implementation.
· Support and execute activities around quarterly performance and management review.
· Assist in Standard Operation Procedures (SOPs) review, writing and editing while working with Company’s stakeholders.
· Host inbound client/regulatory audits, including organizing responses.
· Assist in review and approval of Corrective and Preventive Actions (CAPAs) and related issues, proposed changes and related tasks and enforce execution per established SOPs.
· Support Training program implementation and enforcement.
· Review and maintain regulatory/standards compliance assessments (e.g., FDA, ISO).
· Assist in organizing process for generation of validation documents for releases, and review/approve documents in accordance with established SDLC.
· Qualification of external suppliers following Company’s SOPs (no travel).
· Function as a member of internal audit team.
· Identify process issues or inefficiencies and suggest potential solutions; support other departments in process improvement, ensuring QMS and regulatory compliance.
· Prior experience with conducting/ hosting audits is an advantage but is not required.
· Prior experience with regulated environments is an advantage but is not required.
· Experience with implementation and validation of computerized systems in a regulated environment is an advantage but is not required.
· Prior experience with implementation of ISO standards is an advantage but is not required.
· Excellent customer service skills.
· Continuous improvement mindset.
· Highly skilled in multi-tasking and managing priorities effectively.
· Excellent analytical skills.
· Team player who understands when to ask for help.
· Bachelor’s degree required.