Senior Manager GCP

Essential duties & responsibilities but not limited to the following:

* Assist with development of the audit strategy and programs.
* Assure timely execution of approved audit programs and schedule.
* Provides oversight and directs training of CQA staff in all aspects of the quality management function; especially as it relates to conducting and hosting auditing..
* Identify/monitor GCP compliance risks;provide guidance on mitigation/management of such risks.
* Lead and/or support GCP inspection readiness and inspection management activities.
* Represent CQA in Study Management Team, GCP Compliance Committee, and Clinical Quality System review and improvement teams.
* Lead and/or participate in GCP site and vendor audits in accordance with standard operating procedures, quality policies and/or plans.
* Appropriately and expeditiously escalate GCP compliance issues.
* Communicate audit results to management and auditees through written audit reports.
* Ensure key stakeholders are informed of non-compliances identified during audits.
* Manage post-audit follow-up on any necessary corrective and preventive actions; resolves any conflicts to closure

Requirements:

* Minimum of 8 to 10+ years' experience in the pharmaceutical/biotechnology industry
* Minimum of 7+ years' auditing in one of the following areas: GCP, GLP, GPvP
* Expert knowledge of technical concepts required for all aspects of GCP Auditing, to include all types of GCP audits; e.g., Study Sites, Vendors, essential study documentation
* Solid understanding of domestic and international pharmaceutical/Biotechnology auditing standards
* Extensive experience supporting regulatory authority inspections of clinical research activities
* Hands-on experience managing quality and compliance projects and programs
* Proven ability in driving quality process improvement initiatives.
* Extensive leadership experience and mentoring skills Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines
* Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials
* Experience in providing training on key quality and regulatory compliance information
* Clinical Quality System and Clinical computerized systems; e.g., EDC, IxRS, etc.
* Accomplished knowledge of global and local GCP regulations
To find out more about Real please visit www.realstaffing.com