At Astellas we are making treatments that matter to people We are tackling the toughest health challenges putting the patient at the heart of every move we make. We have developed ground-breaking, innovative medicines in immunology, oncology and urology.
Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
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).
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 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 GCRQA 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
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
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.