Algemene informatie

Job Advert Title
Associate Director PVQA
Locatie
Nederland
Function/Business Area
Legal, Risk, Ethics & Compliance, Quality
Afdeling
PV QA
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Associate Director Pharmacovigilance Quality Assurance


About Astellas:


At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.


About this job:


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


Amongst the main responsibilities for this role are the following:


  • Contributes to the design and strategic direction of the Pharmacovigilance Quality Assurance oversight and support to the Astellas organization in collaboration with the Clinical & Research Quality Assurance 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 Pharmacovigilance Quality Assurance staff as assigned. Provides leadership, development, mentoring and support for direct reports as well as ongoing resource assessment. Responsible and accountable for the Pharmacovigilance Quality Assurance staff recruitment, development and performance management.
  • Develops, manages and allocates resources for execution of the Pharmacovigilance audit schedule for license partners, internal audits, vendors, etc. in conjunction with Clinical & Research Quality Assurance 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/Corrective And Preventive Action). 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 Pharmacovigilance activities and drives their implementation locally and globally as appropriate. Provides guidance, expertise and support to local and global Pharmacovigilance project teams to ensure Good Pharmacovigilance Practice regulatory requirements are met.
  • Manage audit and inspection information in Track wise and/or other electronic systems for reporting and metrics.
 

Essential Knowledge & Experience:


  • Good experience in managing direct reports or contractors in a quality function.
  • Experience in managing a Quality System within a Good x Practice environment. Comprehensive knowledge of Good x Practice and other regulations and understanding of global quality standards relating to product development, submission and/or commercialization.
  • Comprehensive knowledge of Good Pharmacovigilance Practice 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.

Additional information:


  • Currently this position has the flexibility to work from home and in the office.
  • This position is based in Leiden.
  • Full time.

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.