Temp Manager GDQA GCP Auditing
Manager GDQA GCP Auditing-R46111 Position Description As a Manager, GCP Auditing you will build strategic partnerships and implement risk-based quality auditing activities. You will apply your expertise in Good Clinical (GCP), and international regulations to the auditing process to independently address a variety 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 affect 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 aligned with our standard operating procedures and quality policies.
- Internal audits and external audits conducted globally.
- Represent department on teams, complex compliance projects and initiatives both within and across functional areas or other departments.
- May support clinical studies as a strategy representative to develop 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 direct GCP audit experience.
- Experience with FDA and EU regulations and ICH guidance documents are required.