Global Product Compliance Manager

2 weeks ago


Torrington, Connecticut, United States Aptyx Full time
About the Job

Aptyx is seeking an experienced Global Product Compliance Manager to oversee the quality and compliance of our products. This role involves ensuring that our products meet all applicable regulations and standards, and that our documentation is complete and accurate.

Key Responsibilities

The successful candidate will be responsible for developing and implementing quality assurance processes, conducting audits and assessments, and providing training and support to our team. They will also be responsible for maintaining records and reports, and for communicating with regulatory agencies as needed.

What You'll Do
  • Quality Assurance Processes:
    • Develops and implements quality assurance processes to ensure compliance with regulatory requirements.
  • Audits and Assessments:
    • Conducts regular audits and assessments to ensure compliance with regulatory requirements.
  • Training and Support:
    • Provides training and support to our team on quality assurance processes and procedures.
  • Record Keeping:
    • Maintains accurate and complete records and reports as required by regulatory agencies.
  • Regulatory Communications:
    • Communicates with regulatory agencies as needed to ensure compliance with regulatory requirements.
Requirements
  • Bachelor's degree in engineering science or equivalent education/experience.
  • 5-7 years of experience in quality assurance, with a strong background in cGMP and ISO quality systems.
  • Proficiency in MS Office, Excel, Project, and statistical software (e.g., Minitab).
  • CAD/SolidWorks proficiency.
  • Proven problem-solving and data analysis skills.
  • Knowledge of statistical and mathematical functions relevant to quality and process analysis.
  • Excellent written and verbal communication skills in English.
Salary Range

$120,000 - $150,000 per year, depending on experience.



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