Manager/Sr. Manager, QA (GCP)
This position will support all Quality Assurance GCP activities to ensure quality and compliance of Cidara sponsored clinical trials with respect to applicable GCP regulations (e.g., FDA, EU, country-specific), ICH GCP guidelines, Cidara Standard Operating Procedures (SOPs), and current industry standards and practices. Activities will generally fall under the following areas: GCP QA audit program, Cidara quality systems, and internal/clinical study team support. This position reports to Director, GCP QA.
- Schedule, oversee and perform routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, processes, systems and study documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines.
- Provide GCP QA oversight and support to internal staff.
- Represent GCP QA on project teams.
- Review and approve Clinical SOPs.
- Develop and implement Clinical QA SOPs.
- Ensure the timely and effective follow up of all identified or assigned quality issues.
- Assist Clinical Operations in preparing investigational sites for regulatory inspections.
- Support the Director in the QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested.
- Perform CSR audits.
- Perform eTMF audits.
- Manage and/or deliver yearly GCP training for internal staff.
- Bachelor’s Degree in a scientific discipline, a combination of relevant education and applicable job experience may be considered.
- Minimum of 7 years in the Pharmaceutical industry with 3 years in GCP QA.
- Solid understanding of GCP and ICH clinical requirements.
- Experience with both domestic and international clinical studies.
- Able to work independently with minimal direction.
- Able to travel domestically and internationally approximately 25% of the time.
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.
Cidara Therapeutics is an E-Verify Company