A leading pharmaceutical organization is looking for a Remote GCP Director to head their bioanalytical vaccine business unit. With many laboratory services they provide, this is a great opportunity to work with a variety of different therapeutic areas specializing in human clinical trials that are currently underway!
- Provide direction in support of customer / functional accounts, audit and inspection programs, and the QA quality management systems.
- Drive quality improvements and efficiencies along with risk mitigation based on QA data analyses, operational performance data, knowledge of process management, changing regulations and customer expectations
- Lead and project manage internal QA quality improvement initiatives
- Recommend process and systems for audit, write systems audit plans, and oversee the delivery of these audits, review the Corrective and preventive actions (CAPAs) and ensure appropriate follow up
- Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections.
- 2 Direct Reports: 1 Manager in Ithaca (in charge of auditing) and the other in Raleigh.
What they Need:
- 12 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience.
- 5 years of management experience.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Ability to manage costs effectively through appropriate resource allocation.
- Experience with clinical trial sponsor, customer relations.
- Regulatory inspections