Associate Director - Pharmacovigilance (QA)

Description

The Associate Director provides leadership and strategic direction to the Pharmacovigilance Quality Assurance (PV QA) Team which is responsible for QA oversight of Pharmacovigilance activities to ensure compliance with (inter)national regulatory requirements for Good Pharmacovigilance Practice (GPVP). This position will collaborate closely with Global Clinical & Research Quality Assurance (GCRQA) peers and teams in other Astellas regions to provide comprehensive quality oversight and quality assurance for Astellas Pharmacovigilance activities.

• Contributes to the design and strategic direction of the PV QA oversight and support to the Astellas organization in collaboration with the GCRQA Leadership Team and stakeholders locally, regionally and globally. Directs the development of this approach and its implementation to ensure an effective audit program that complies with regulatory requirements and stakeholder expectations is developed and executed.
• Anticipates and proactively responds to trends and/or shifts in the external Pharmacovigilance environment (e.g., Regulatory Agency, regulations, industry standards, customers) by assessing impact and ensuring robust Quality Systems meet these external requirements, trends and expectations.
• Manages and directs the PVQA staff as assigned. Provides leadership, development, mentoring and support for direct reports as well as ongoing resource assessment. Responsible and accountable for the PV QA staff recruitment, development and performance management.
• Develops, manages and allocates resources for execution of the PV audit schedule for license partners, internal audits, vendors, etc. in conjunction with GCRQA colleagues and stakeholders to ensure an effective audit program that complies with regulatory requirements and stakeholder expectations.
• As assigned, act as Primary Inspection Administrator for the facilitation and management of regulatory agency inspections and customer/license partner audits. This includes management of preparation activities through response development and follow-up of commitments
• Provides leadership and guidance to the functional groups for significant issue management (deviation/CAPA). Ensures appropriate implementation of corrective actions and quality system improvements. Leads an effective escalation process for management of deviations, analysis of risk and measuring effectiveness.
• Drives new ideas and innovation to promote process improvement and risk mitigation to support Pharmacovigilance and overall Astellas’ Quality Systems. Develops short and long-term risk-based quality

Your Profile

• BA / BS or equivalent, with 9+ years of industry experience, 5 years of QA experience, and 3 years managing staff or outsourced resources.
• Experience in managing a Quality System within a GxP environment. Comprehensive knowledge of GxP and other regulations and understanding of global quality standards relating to product development, submission and/or commercialization.
• Comprehensive knowledge of GPVP and other regulations for pharmaceuticals and biologics and understanding of global quality standards and regulatory authority inspection trends relating to product development and submission, as well as commercialization. Demonstrated ability to establish local and regional Quality policies and to influence the development and implementation of global Quality policies in support of the quality system.
• Excellent interpersonal, communication and presentation skills
• Ability to initiate, build and maintain strong cross-functional and cross-divisional business relationships and positively influence key, strategic position holders across locations and functions.