Director, Clinical Quality Assurance
In this role, you'll help make sure the company follows global quality and safety standards (GxP) by supporting audits and inspections. You'll work with different teams to solve quality issues, investigate problems, and help improve how things are done.
You'll need to be comfortable working in a fast-moving, innovative environment and be able to work well with others under pressure to meet deadlines and stay compliant with regulations.
Key Responsibilities:
- Oversee quality for clinical trials and drug safety activities.
- Lead or assist with audits of internal teams, suppliers, and clinical sites.
- Create audit plans, carry out audits, and report findings.
- Help clinical sites get ready for inspections (online or in person).
- Manage and improve some quality processes.
- Identify risks and ensure quality standards are met.
- Work with teams to fix and prevent quality issues.
- Help prepare for inspections by agencies like the FDA.
- Support efforts to ensure data is accurate and trustworthy.
- Stay up to date on regulations and train others on changes.
- Review documents and data for quality.
- Help write or update quality procedures and tools.
- Train and mentor others on quality standards.
- Join meetings to discuss audits, issues, and progress.
- Review quality performance data regularly.
- Travel up to 20%, including international trips to prepare sites for inspections.
Key Qualifications:
- Bachelor's or Master's degree in a science-related field. Advanced degree preferred.
- Minimum of 10 years if Clinical QA experience within the pharma or biotech industry.
- Extensive experience and strong understanding of the Quality Management Systems and its philosophy.
- Knowledge and experience with GMP, GVP, and/or GLP is a plus.
- Oversight and management of QMS in a plus.
FAQs
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