• Pre-clinical/Life Sciences
  • Bedford, MA

Position Purpose:

We are seeking an enthusiastic and highly motivated Director/Senior Director, Quality Assurance to join the Quality group. The successful candidate will be responsible for: helping to define, communicate and implement the company’s quality strategy and vision.

Key Responsibilities Include:

  • Provide strategic and proactive QA leadership in alignment with Global Head of Regulatory Affairs & QA
  • Responsible for the operational management of local Quality Management System (QMS) covering GCP and/or GMP activities of a biotech company in alignment with corporate QMS.
  • Manage and oversee the local QMS e.g.
    • SOP system
    • Training system
    • Audit system covering GCP & GMP audits
    • Batch disposition, recall, and field alert system
    • Risk Management system
  • Provide guidance, interpretation, support, training, and key input to relevant stakeholders in the company for consultation and interpretation of regulations, guidelines, corporate standards, and SOPs
  • Development of employees (as the role grows)
  • Provide input to budget planning and oversee budget for your area of responsibility
  • Ensure inspection readiness

Required Experience:

  • Bachelor’s Degree or above in a Science/Engineering or related field.
  • 10 years’ experience preferred in the pharmaceutical/biotech industry and in QA, including direct experience in a GxP environment
  • At least 5 years of demonstrated leadership experience in leading QA professionals
  • Experience in performing audits of GMP and/or GCP areas highly desirable
  • Experience in setting up quality system in GMP and/or GCP area
  • Detailed knowledge of cGMP and GCP regulations (such as 21CFR part 210, 211, 312, 314 etc.) and guidelines (e.g. ICH GCP)
  • Independent self-starter is a must

Travel:

Approximately 10-20% of this position will require travel.

Submit Resume

To apply for this job email your details to info@clinlabstaffing.com