Associate Director, GLP/GCP Compliance

This position is responsible for developing, implementing, and maintaining all aspects of R&D Quality and GCP Compliance at Homology Medicines to ensure compliance with applicable regulatory requirements. Areas of responsibility within R&D include deviations, CAPA and SOP management, documentation control, records management, and vendor selection and compliance management.

Principal Duties and Responsibilities

  • Responsible for developing, implementing, and maintaining a scalable R&D quality infrastructure within the Homology Medicines Quality Management System, to include: Documentation, internal and external GCP/GLP audits, investigations, deviations and record review, and data quality control
  • Responsible for ensuring that a strategic GCP audit plan is designed and implemented
  • Ensures that investigator, vendor, GCP facility and system audits are conducted, results are communicated, and appropriate corrective actions are implemented
  • Supervise and oversee the analysis of audit program results, quality issues and investigations
  • Contributes to GCP vendor selection as well ongoing evaluation of the vendor’s overall compliance performance
  • Represents Homology Medicines during GCP regulatory inspections
  • Assures that responses are timely and appropriate to maintain good standing with global regulatory agencies
  • Provide GCP oversight and document QC, including trial master files, CSRs, protocols, regulatory submission documents, etc.
  • Assist with ICH/GCP Training at investigator meetings and internally
  • Insure inspection preparedness, including conducting of mock audits

Skills & Experience

  • Bachelors Degree in a scientific discipline with a minimum of 8 years of experience in GCP/GLP/GXP in the pharmaceutical industry, advanced degree considered a plus
  • Ability to evaluate complex situations and to render judgements in the context of significant legal, financial, and regulatory risks and where compliance guidelines are vague or not available
  • Strong team building and leadership skills
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills
  • Ability to analyze complex issues and develop relevant and realistic plans and recommendations
  • Strong written and oral communication skills

Interested candidates should forward a cover letter and resume / CV to careers@homologymedicines.com