MANAGER, CLINICAL QUALITY ASSURANCE (GCP)
This position is based in San Diego working with both development and commercial products. Will be responsible for day-to-day Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas. Additionally, the successful candidate will assist with providing Quality Assurance (“QA”) support and training to ensure adherence with applicable regulatory requirements and company policies/procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:
Good Clinical Practice (“GCP”) Audit Management:
- Coordinate, conduct, and/or oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures.
- Assist with the development and maintenance of the CQA audit schedule, files, and audit database/tracker.
Study Team Support:
- Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks; intervene when sub-optimal performance is identified.
- Assist in remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance.
- Provide GCP training as needed.
- Work with a multidisciplinary team to help standardize clinical development activities within and across programs through preparation of SOPs and personnel training.
- Assist with implementing quality systems, processes and procedures within CQA area.
- Conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting.
- Proactively identify areas for improvement, and collaborate with QA and GCP departments on continuous improvement initiatives.
QA Department Support:
- Assist with identifying, implementing and training all departments that utilize GCP principles on improvements and applicable regulations and guidelines.
- Work closely with QA management to ensure compliance to regulations, guidelines and company SOPs.
- May work on other projects within QA not related to GCP and other duties as assigned.
In-depth knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired.
Ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to investigator sites as well as the Company’s management.
Proven track record and experience in searching, review and implementation of regulatory requirements and guidelines including research of principal investigator regulatory histories. Ability to identify and escalate problems and follow-through with the corrective actions.
Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors.
Proven ability to quickly learn new information and communicate requirements to the appropriate individuals.
Must possess strong verbal and written communication skills along with sound organization skills applicable to audit planning, reporting and archiving.
Travel may be required up to 25%.
EDUCATION and/or EXPERIENCE:
RN, BSN, BS/MS, or BA degree or equivalent experience in scientific or health care field, and minimum of 8 years industry experience of which 5 years must be CQA experience in drug development.