Support, maintain, and lead the Internal Audit Program to help ensure compliance to applicable regulations and directives
Participate in site internal audits as a team or lead auditor to ensure compliance with all applicable quality system standards
Lead inspection readiness activities and actively participate in external audits and inspections
Manage assigned internal and external audit observations to ensure identified gaps are closed in a timely manner
Execute internal audits against established procedures
Create reports and communicate performance against metrics to key stakeholders
Support preparation of external audit and inspection responses
Connect and collaborate with other region’s compliance teams
Provide compliance education and training (QSR, ISO, GMPs) to the organization
Support and promote the safety and environmental objectives of the facility

A minimum of a Bachelors or equivalent University degree
6 – 8 years or more experience in a FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry
Experience leading internal quality system audits
Proven leadership skills in associate involvement and teamwork
Initiative, creativity, assertiveness, attention to detail, excellent interpersonal skills
Ability to work under pressure achieving consistently high results in quality, efficiency, and compliance through individual and team efforts
Ability to analyze complex data and integrate multi-disciplinary feedback
Expertise on the new Quality System Regulations
Knowledge of quality and manufacturing systems & processes and applicable regulations (ISO 13485, MDD 93/42/EEC and amendments, MDR and other applicable regulations)
Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required

Staff Regulatory Compliance Specialist

Key skills