At Astellas, experience is coupled energised with a relentless challenger spirit.

We are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.

We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.

We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.

About This Job

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 Clinical & Research Quality Assurance (CRQA) 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 CRQA Leadership Team and stakeholders locally, regionally and globally. Directs the development of this approach and its implementation to ensure an effective audit program which 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 CRQA colleagues and stakeholders to ensure an effective audit program which 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 strategies in support of PV activities, and drives their implementation locally and globally as appropriate. Provides guidance, expertise and support to local and global PV project teams to ensure GPVP regulatory requirements are met.
• Manage audit and inspection information in Trackwise and/or other electronic systems for reporting and metrics.

Essential Knowledge & Experience

• One to three years’ experience in managing direct reports or contractors in a quality function.
• 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
• Strong organization 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.
• Influencing skills with a demonstrated ability to lead projects, initiatives, and programs across multiple departments, regions and business units within Astellas and with external stakeholders.
• Demonstrated ability to solicit input and liaise with stakeholders to prioritize and set strategic direction for change.

Preferred Knowledge & Experience

• Advanced degree is preferred.
• Quality assurance / auditing certification or credentials through recognized quality standards organization is preferred.

Educations/Qualifications

• Bachelor’s degree with 10+ years of industry experience, 5-7 years of QA experience

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.