Description
Position Summary
This position will be responsible for management of Cidara’s Quality Assurance Systems, which include the GXP Training program; management of GXP Controlled Documents (Standard Operating Procedures, Forms, etc.); Quality Events (Deviations, CAPA, etc.); and Change Control. The position will also provide support for GMP clinical supplies activities to ensure that they are conducted in compliance with applicable GXP requirements and regulations. This position reports to the Sr. Director of Quality Assurance.
Responsibilities
- Serves as Business Administrator for Cidara’s electronic quality management system (eQMS), maintaining and updating system configuration and validation status.
- Manages the GXP Training program, including annual reviews of training files and tracking of training requirements and completion.
- Manages the GXP Controlled Document system, including processing SOPs, Forms and other equivalent documents in the Document Control system, conducting Quality Assurance review of departmental Controlled Documents as needed, and ensuring periodic review of SOPs.
- Manages the Quality Event system, comprising internal deviations, CAPAs and complaints, and tracks their completion and approval extension of dates, as applicable.
- Manages the Change Control system and tracks their completion through the CMOs.
- Serves as primary quality assurance support for clinical supplies GMP activity, including review and approval of packaging work order/batch record documentation, clinical label documentation, and related quality events.
- Identifies problematic areas, provides suggestions for resolution, and monitors the approved action plan and timeline for resolution.
- Communicates and presents issues to Quality Assurance and functional area management.
- Assists in the implementation of other internal Quality Assurance Systems, including reviewing or writing Quality Assurance departmental SOPs.
- Assists in Quality Investigations as necessary.
Minimum Qualifications
- Bachelor’s Degree, preferably in a scientific discipline; a combination of relevant education and applicable job experience may be considered.
- 6-8 years of relevant experience in the biotech/pharmaceutical industry
- Solid understanding of GXP requirements (GMP experience is preferrable) and Good Documentation Practices
- Demonstrated ability to resolve issues proactively
- Excellent written and verbal communication skills, as well as interpersonal skills
Location
San Diego – Hybrid
Salary Range
$120,000 to $140,000 per year The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the years of relevant industry experience, education, and skills/abilities. 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
