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Senior Compliance Auditor

Cambridge, MA 02139

Posted: 05/16/2024 Employment Type: Direct Hire/Perm Job Category: Administrative Job Number: 617371 Country: United States Is job remote?: No

Job Description



Essential Functions:
  • Accountable for project completions and achievement of compliance goals.
  • Perform internal audits to ensure compliance to applicable regulations such as GMPs, 820 and requirements.
  • Lead and support supplier and service provider audits (onsite and paper questionnaires) to ensure compliance with GMPs, applicable regulatory requirements and requirements.
  • Support the Supplier Management Program, including the drafting and maintenance of Quality Technical Agreements, where required.
  • Address and/or escalate compliance problems and issues to the Supplier Management Team (SMT) for supplier issues and Quality Management for internal issues.
  • Provide support to the SMT through meeting participation and discussions.
  • Provide support to medical device suppliers (CMO) project teams for issue resolution or questions.
  • Provide and/or revise Standard Operating Procedures.

Leadership Responsibilities:

Understanding, observing, and adhering to the goals and policies outlined in Code of Business Conduct and Ethics
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make a great place to work, and a company respected for the quality of its people and products.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.


Basic Qualifications:
  • Bachelor's degree or equivalent with 15 years of experience in a quality unit within the pharmaceutical/biotech industry.
  • Five years of experience auditing as a qualified auditor of suppliers for compliance with cGMP, QSR and ICH regulations.
  • Knowledge of relevant FDA regulations/guidance and ICH Guidelines.
  • Ability to plan/execute and report audits independently.
  • Experience in cell manufacturing/biologics, medical devices, and/or software quality.
  • Exposure to Good Clinical Practice (GCP) and ICH E6.

Preferred Qualifications:
  • Basic knowledge of GMP regulations.
  • Experience with electronic Quality Management Systems.
  • Expert knowledge of GMP, QSR regulations.
  • Proficient in MS Office.
  • Strong communication, organization and time management skills.
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