Senior Qa Manager Operations

J&J FAMILY OF COMPANIES

Añasco, Puerto Rico, United States of America
Quality system supervision
Regulatory compliance (qsr, iso)
Validation and verification activities
Supervise the personnel, deployment and execution of the Quality System within the primary areas of responsibility to ensure compliance and to support the effectiveness and efficiency of the manufacturing process

Job Summary

  • Supervise the personnel, deployment and execution of the Quality System within the primary areas of responsibility to ensure compliance and to support the effectiveness and efficiency of the manufacturing process.
  • Serve as Quality Assurance/ Engineering SME for assigned areas and work with multi-functional teams to establish operational plans and ensures uninterrupted support to manufacturing operations.
  • Lead or aids in the execution of validation and verification activities associated with process, equipment, csv, laboratories and test methods, and conduct and/or participate in troubleshooting and/or deviation investigation efforts.

Matching Summary

Supervise the personnel, deployment and execution of the Quality System within the primary areas of responsibility to ensure compliance and to support the effectiveness and efficiency of the manufacturing process.

Skills & Requirements

Must-have

  • Quality System Supervision
  • Regulatory Compliance (QSR, ISO)
  • Validation and Verification Activities
  • Process Robustness Initiatives
  • Risk Management Implementation
  • Six Sigma / Process Excellence Projects

Nice-to-have

  • Mentoring and Coaching Skills
  • Cross-Functional Collaboration
  • Fact-Based Decision Making
  • Inclusive Leadership
  • Tactical Thinking

Key Requirements

  • BS in Engineering required
  • 8 years of work experience in Quality Engineering/Assurance
  • Experience in Pharmaceutical or Medical Device Industry
  • Managing and hosting regulatory bodies
  • Experience with validation, cGMPs and/or GLPs
  • Fully bilingual (English/Spanish)

Work Rights

Not specified

Tailored Resume

Cover Letter