What are the responsibilities and job description for the Regulatory Compliance Specialist position at Kelly Science, Engineering, Technology & Telecom?
Regulatory Compliance- Operations & Manufacturing
Permanent Position- Onsite
Job Summary
- Lead and execute regulatory compliance operations programs across global operations. The position plays a critical role in audit readiness, remediation of compliance issues, governance development, and continuous improvement initiatives at both enterprise and site levels.
Regulatory & Quality Compliance
- Lead remediation of regulatory compliance issues related to enterprise standards, local procedures, and global regulations (FDA, EU MDR, ISO, MHRA, DSCSA, State Board of Pharmacy).
- Serve as a SME on regulatory compliance requirements supporting operations and manufacturing.
Audit & Inspection Readiness
- Drive inspection readiness activities, including training, audit logistics, request management, and daily audit communications.
- Lead Internal Audit (IA) and External Audit (EA) programs, including planning, execution, reporting, and follow-up.
- Develop and maintain audit policies, procedures, schedules, playbooks, templates, and metrics.
- Serve as backroom lead and primary point of contact during regulatory inspections and Notified Body audits (announced and unannounced).
- Remediate audit findings and lead CAPA investigations and execution.
Program & Process Development
- Design and implement vendor license verification processes and manage third-party regulatory compliance tools and databases.
- Establish and manage State Board of Pharmacy licensing programs, including applications, renewals, monitoring, and record retention.
- Develop and implement governance frameworks, policies, procedures, and work instructions to support regulatory compliance.
Cross-Functional Leadership & Training
- Collaborate with global and regional stakeholders to support strategic initiatives and technology-driven regulatory compliance enhancements.
- Lead and facilitate global training programs on regulatory compliance topics, including EU MDR, CAPA, inspection readiness, data integrity, and combination products.
Required
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field
- 7 years of experience in Regulatory Compliance and Audit Management within a GMP regulated or pharmaceutical environment.
- In-depth knowledge of FDA regulations, EU MDR, ISO standards, MHRA requirements, and audit processes.
- Proven experience leading internal and external audits, inspections, and global compliance initiatives.
Preferred
- Lead Auditor certification
- Experience managing DSCSA compliance and State Board of Pharmacy licensing.
- Experience supporting global organizations and cross-regional stakeholders.
- Strong project management, communication, and stakeholder-influencing skills.
Key Competencies
- Regulatory compliance expertise and audit leadership
- Inspection readiness
- Auditing a manufacturing environment where operations are occurring