Senior Manager, Pharmacovigilance Quality Assurance

Job Description

At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.

What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.

About Us:

We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.

In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.

We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.

From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.

Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.

Description
Responsible for the development and maintenance of excellence in Pharmacovigilance QA (PVQA) activities supporting the PV system and Quality Assurance. The Manger, PVQA provides support in ensuring Astellas processes and comply with national and international requirements for the pharmacovigilance function and the collection and systems reporting of safety information.

This activity comprises both auditing as directed, and consultancy activities. This role develops and manages a sub selection of the quality system and operations across region. As QA Expert, provides QA consultancy (identifying risk, leading continuous improvement) services to the organization for the Pharmacovigilance and related functions. This role will coordinate the preparation, the conduct and the follow up of Regulatory Inspections as directed.

Essential Job Duties

• Execution of regional, cross regional and/or global multiple audit programs. This includes the planning, conducting, and reporting of audits, liaising with customers on audit findings and the follow up thereof. It also incorporates interpretation of findings, providing trending information, root cause analyses and identifying lessons learned for Astellas organization continuous improvement. Lead the proper management and follow up of the findings and improvement areas.
• Provide unsupervised GPvP expert advice to key personnel. This includes and is not limited to: Developing training materials and providing GPvP training internally and externally to both small and large professional organizations. It also encompasses coaching of QA colleagues and other functions, on QA related processes. Reviewing of the responses/communication provided to health authorities (e.g. in case of inspection). Interpreting health authorities’ requirements and advising in their implementation across Astellas organization.
• Responsible for preparation of the different Astellas entities and or partners to any regulatory inspection. Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program across the departments and the territories ensuring harmonized approach.
• Work with the PVQA leadership in identifying needs for outsourcing, selecting, managing, and evaluating 3rd Party QA service providers to which audit and/or consultancy activities are being outsourced. This includes providing training, managing financial information and maintaining effective interfaces to ensure that output meets defined expectations in terms of content and timelines.
• Support the development, improvement and maintenance of the Astellas Quality System by signaling root causes to non-conformances related to the system, by addressing observed gaps in the system.
• Manage Quality Issues related to critical non-conformities, serious misconduct and potential fraud. Lead proper corrective and preventive actions identification and roll out and ensure follow up with effectiveness measures.
• Develop, analyze and report relevant key performance indicator information.
• Manage GxP inspections. This includes communication with Regulatory authorities, Inspection preparation, hosting, support of CAPA generation and monitoring of follow up to ensure that any risk / non-conformance as identified by inspectors is adequately addressed and mitigated.
• Develop and manage interfaces with QA departments of service providers, to ensure QA oversight of the service provider and that any risk to Astellas business is being mitigated.

Requirements

Required Qualifications

• Bachelor’s degree
• Seven (7) years’ experience in clinical/Pharmacovigilance QA, or in the pharmacovigilance function.
• Excellent knowledge of QA Standards, particularly Good Clinical and/or GPvP Practice Guidelines and Regulations and other related areas as specific for the function (e.g. PV), as well as basic legal regulations.
• Very good interpersonal and communication skills.
• Ability to influence without authority.
• Project Management Skill.
• Excellent attention to details.
• Flexibility and Adaptability

Preferred Qualifications

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