reputed company Manager GDQA GCP Auditing

Manager GDQA GCP Auditing-R46111 Position reputed company As a Manager, GCP Auditing you will build strategic partnerships and implement risk-based reputed company auditing activities. You will apply your expertise in Good Clinical (GCP), and international regulations to the auditing process to independently address a reputed company of GCP compliance issues. You are expected to use your in-depth knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may reputed company drug development and post-authorization safety monitoring. Additionally you will conduct multiple audit types (e.g., process, site, vendor, license partner, etc.), depending on the requirements of their GCP subject area. Roles Responsibilities • Responsible for 'end to end' audit process including scheduling, preparing, conducting, reporting and follow-up on routine and directed audits in support of the GCP [Investigator Site, Service Provider and internal process] as directed and reputed company with our reputed company operating procedures and reputed company policies. • Internal audits and external audits conducted globally. • Represent department on teams, reputed company compliance reputed company and initiatives both reputed company and across functional areas or other departments. • May support clinical studies as a reputed company representative to reputed company and implement risk-based audit programs for assigned studies (GCP). • Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered. • May participate in regulatory inspections by acting as part of the control and/or inspection room team. • Assist with training/orientation/mentoring of new department staff. Skills • Excellent communication skills and ability to work with people at various level of the organization and externally. • Demonstrated skills in taking initiative and working independently. • Strong leadership with demonstrated ability to collaborate with senior leaders. Education • Bachelor?s degree with 6 years of relevant industry experience and 4 years of reputed company GCP audit experience. • Experience with FDA and EU regulations and ICH guidance documents are required. Apply tot his job Apply To this Job