Staff Regulatory Compliance Specialist
Johnson & Johnson
full-time
Posted on:
Location Type: Office
Location: San Jose • California • United States
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Job Level
About the role
- 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
Requirements
- 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
Benefits
- Inclusive work environment
- Professional development opportunities
- Health insurance
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
internal auditsquality system auditsdata analysiscompliance metricsquality system regulationsISO 13485MDD 93/42/EECMDRGMPs
Soft Skills
leadershipteamworkinitiativecreativityassertivenessattention to detailinterpersonal skillsability to work under pressurehigh results orientation