The Senior Regulatory Compliance Consultant works independently on compliance activities and provides guidance to other Regulatory Compliance Consultants.
Serves internal and external customers as a Subject Matter Expert for compliance topics
Creates and updates SOPs following a strict document control process
Advises teams on best practices for meeting compliance requirements
Plans and performs internal audits as a lead auditor
Performs peer reviews for Audit Plans and Audit Reports generated by other team members
Represents the compliance team in external audits
Stays abreast of industry compliance topics and identifies training needs
Performs CAPA resolution for the QRC team and assists other teams with CAPA resolution for findings in their areas
Tracks metrics across compliance initiatives and suggests opportunities for improvement
Participates in formal Risk Assessment and Risk Remediation activities
Participates in initiatives to achieve new compliance as recent requirements emerge (such as GDPR, NIS2)
Skills
Audit: Experience planning and conducting internal audits, identifying nonconformities, writing audit reports, giving feedback, and tracking CAPA progress.
Communication: Excellent communication skills, both verbal and written, with the ability to effectively reach audiences with varying levels of compliance knowledge
Initiative: Ability to identify areas of need and propose solutions without being prompted
Coaching: Ability to effectively coach teams and peers on compliance topics
Independence: Must be able to structure own tasks and work independently, with limited supervision
Organization: Must understand requirements for records storage and plan for efficient retrieval during audit
Education / Qualifications
Bachelor’s degree in Computer Science, Engineering or equivalent technical experience
3 to 5 years experience in quality, security or regulatory