Director of Toxicology
RQM+
Quality Manager / Sr. Manager, Good Laboratory Practices
Vertex Pharmaceuticals
contract
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $75 - $85 per hour
Job Level
Senior
About the role
- Support the GLP Operational Quality team and business partners in driving quality outcomes and operational excellence.
- Maximize the value, impact, and delivery of quality oversight activities to ensure compliance and excellence in quality.
- Collaborate with the Quality Analytics team to develop meaningful quality indicators for ongoing evaluation of process and quality system health, and risk identification.
- Work closely with other R&D Quality members to support scalable quality approaches and ensure consistency in execution across products and programs.
- Participate in regulatory document reviews, identifying potential risks or gaps in Investigator Brochures, INDs, BLAs, and NDAs.
- Provide input in the development of audit scope and focus for vendor audits.
- Contribute to proactive inspection readiness activities by conducting quality assessments of GLP studies on-site or remotely.
- Collaborate with preclinical stakeholders and quality partners to develop appropriate metrics related to GLP activities.
- Participate in creating and presenting content for annual GLP refresher training.
- Perform other duties as assigned.
Requirements
- Bachelor's degree or equivalent in a related scientific field.
- Strong experience in GLP (Good Laboratory Practices) and reviewing data and documents supporting GLP studies and submissions.
- Experience in Pharmaceuticals or Contract Research Organization (CRO) preferred.
- RQAP-GLP certification preferred but not mandatory.
- Ability to work independently and meet timelines in a fast-paced environment.
- Excellent communication and collaboration skills.
- Willingness to travel up to 20% (visiting CROs, some travel to Boston).
