Manager, Quality Assurance
An excellent opportunity for a permanent hire Clinical QA Manager needed for a dynamic growing pharmaceutical company based in San Diego working with both development and commercial products. Will be responsible for Clinical Quality Assurance (CQA) in support of research projects across multiple therapeutic areas. Additionally, the successful candidate will assist with providing 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:
Perform investigator site and vendor audits to assess the integrity of the study data and to determine if studies are being conducted in compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures.
Coordinate all GCP related audit activity including management and maintenance of the CQA audit schedule and observation trending.
Monitor the regulatory status of principal investigators and intervene when sub-optimal performance is identified. Assist in remediation and corrective action plans to ensure all parts of the study are conducted properly.
Perform internal audits designed to determine if policies/procedures, systems, reporting and/or the conduct of the investigational studies are executed with compliance to GCP principles/regulations.
Work with a multidisciplinary team to help standardize clinical operational activities within and across programs through preparation of SOPs and training of in-house personnel.
Implement quality systems, processes and procedures within the CQA area.
Support the QA department by 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.
In-depth knowledge of all Clinical Trial related FDA regulations, 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 management.
Proven track record and experience in searching and review 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 implementing them effectively to reduce errors.
Proven ability to quickly learn new information and communicate this to the right individuals.
The candidate 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 with 8+ years of experience of CQA in drug development.