Sr. Director Of GCP

This position is for a mid-size pharmaceutical company in San Jose. They currently have commercial products in the EU and Canada, while phase III trials are currently on going in the US. I have the responsibility of finding their new head of GCP, who will be responsible for building out their own team to oversee the clinical compliance department.

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.
* Monitor and maintain CQA operations within budget.
* Ensure timely development of audit schedule, assist in the preparation and conduct audits in support of all GCP activities as directed.
* In collaboration with the Director, CQA, ensure that appropriate Standard Operating Procedures are in place
* Manage and coordinate the activities of the audit teams
* Lead and/or participate in GCP site and vendor audits in accordance with the company's standard operating procedures, quality policies and/or plans.
* Interpret policies, standards, and regulations, and applies to evaluation of potentially critical problems Exercises sound and balanced judgment in evaluating compliance of quality systems, processes, procedures, and protocols.
* 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
* Develop and manage periodic reports of key Clinical Quality metrics to management as requested.
* Assist with training/orientation/qualification of new CQA Auditing staff
* Travel required up to 35% as needed (travel may be domestic and international)
To find out more about Real please visit www.realstaffing.com