Senior Auditor/Manager, Clinical Quality Assurance
We are currently seeking a motivated and enthusiastic individual to become a member of our growing Quality Assurance team.
Responsibilities include
* Assuring that Phase I-III clinical studies are being conducted in accordance with the protocol and Good Clinical Practice (GCP) standards and regulations;
* Assuring that the organization is working in accordance with GCP standards and regulations;
* Developing program-specific audit schedules based on risk;
* Designing, implementing, conducting, and follow-up GCP audits in accordance with the audit schedules
* Investigator site audits
* Vendor audits
* Document audits (Clinical Study Reports, Protocols, etc.)
*Internal audits of Clinical processes and/or systems
* Managing consultant auditors;
* Assisting in developing departmental written procedures and templates;
* Assisting in developing and implementing an internal systems and processes audit program;
* Assisting in developing and implementing a GCP training program;
* Presenting GCP information at investigator meetings and at Clinical Operations training sessions;
* Acting as a GCP resource for the organization.
Requirements:
B.A. or B.S. degree or equivalent training and experience. 4+ years of experience in the pharmaceutical industry with at least 3 years in Clinical Operations or Clinical Quality Assurance (GCP focus). A thorough understanding of the drug development process. Strong understanding of FDA 21 CFR Parts 11, 50, 54, 56, 312, International Conference of Harmonization (ICH) GCP (E-2A, E-3 and E-6), and other GCP standards. Internal system and process audit experience. Regulatory agency inspection experience. Ability to manage multiple tasks with competing priorities. Demonstrated ability to work both independently and as part of a team. Excellent verbal and written communication skills. Desire and ability to travel. Qualified candidates must be able to work independently and have excellent organizational, communication and problem solving abilities.