Director Quality Assurance and Regulatory Affairs in Pittsburgh, PA at Apex Life Sciences

Date Posted: 8/7/2018

Job Snapshot

Job Description


Apex Life Sciences is currently recruiting for someone to be responsible for developing and administering Quality System and ensuring product meets the established standards of quality.  Incumbent would be responsible for Regulatory Affairs and compliance to regulatory standards, FDA, EU, etc for company.  Reports to Chief Quality Officer

Responsibilities:

  • Draft quality assurance policies and procedures
  • Responsible for document management system
  • Interpret and implement quality assurance standards
  • Develop, recommend and monitor corrective and preventive actions
  • Develop and manage Supplier Quality program
  • Evaluate adequacy of quality assurance standards
  • Devise sampling procedures and directions for recording and reporting quality data
  • Plan, conduct and monitor testing and inspection of materials and finished products
  • Document internal audits and other quality assurance activities
  • Analyze data to identify areas for improvement in the quality system
  • Prepare reports to communicate outcomes of quality activities
  • Identify training needs and ensure cGMP training for all employees
  • Coordinate and host audits, FDA inspections
  • Assure ongoing compliance with quality and industry regulatory requirements
  • Understand and stay up to date with current FDA and EU regulatory requirements, guidances that pertain to company products.
  • Develop and write documents for regulatory submission, IND, BLA, technical dossier.
  • Support product development needs from QA/RA perspective

Requirements:

  • Bachelor’s degree in life science or engineering
  • Experience with implementation of Quality system for startup company preferred
  • Regulatory Affairs experience
  • Regulatory Compliance experience
  • Experience with Quality System development in pharma, biologics, or Class 3 devices
  • Strong computer skills including Microsoft Office and databases
  • Knowledge of tools, concepts and methodologies of QA
  • Knowledge of FDA regulations in Biologics and Blood products preferred

CONTACT: dfratantonio@apexlifesciences.com

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.