Responsibilities
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 current 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,