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Pharmacovigilance Quality Director

UMMARY: Qualified candidates will be responsible for developing and executing global quality oversight for all aspects of pharmacovigilance (PV) activities. -Will organize audit activities across headquarters, global affiliates and third party vendors.             -Manages all PV system audits and communicates findings to key stakeholders. -Will collaborate with key stakeholders including PV, Quality Risk Management, Legal, Regulatory, Clinical Operations and Commercial Operations to develop appropriate CAPAs in response to identified PV quality issues and observations. -Manages external vendors involved in PV auditing and/or training activities. -Ensures detailed tracking and completion of CAPAs on a crossfunctional basis. -Manage a team of PV auditors. Establish performance objectives and rolling audit plans. Ensure excellence and independence of PV audits. Review and approve internal audit reports. -Identify PV risks and support the implementation of PV quality risk mitigation plans where appropriate. EDUCATION & EXPERIENCE: -Qualified candidates must have 8-10 years experience in pharmacovigilance and quality assurance in both tactical and strategic capacities. -Must have a minimum Bachelor’s degree in life science required. Advanced degree strongly preferred. -Must have established expertise and training in GxP systems. Extensive knowledge of global regulations and standards. -Must have experience directing audit planning and overseeing audit functions on a routine basis.  

Longview, Texas