Senior Manager, Pharmacovigilance Quality Assurance

Astellas Pharma Inc.; Markham; On-site; CAD 100,000 - 130,000; Full time

Job summary

A leading global pharmaceutical company is seeking a QA Manager for Pharmacovigilance based in Markham, Canada. This role will focus on ensuring compliance with QA standards, managing audits, and liaising with regulatory authorities. Candidates should have seven years of experience in pharmacovigilance QA and strong project management skills. This position is critical for maintaining high-quality standards and managing inspections effectively.

Qualifications

• Seven (7) years’ experience in clinical/pharmacovigilance QA.
• Excellent knowledge of QA Standards and Good Clinical Practice.
• Strong project management skills and attention to detail.

Responsibilities

• Coordinate and perform audits and inspections for pharmacovigilance activities.
• Provide expert advice and training on Good Pharmacovigilance Practices.
• Manage relationships with regulatory authorities and service providers.

Skills

Excellent knowledge of QA Standards

Very good interpersonal and communication skills

Ability to influence without authority

Project Management skills

Excellent attention to detail

Flexibility and adaptability

Education

Advanced degree preferred

Quality assurance/auditing certification preferred

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 Manager, 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 the region. As a 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.

• 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 responses/communications provided to health authorities (e.g., in case of inspection). Interpreting health authorities’ requirements and advising on their implementation across Astellas organization.
• Responsible for preparation of the different Astellas entities and/or partners for any regulatory inspection. Analyze risks, propose strategies for readiness, and manage the implementation of readiness programs across departments and territories, ensuring a harmonized approach.
• Work with PVQA leadership to identify needs for outsourcing, select, manage, and evaluate 3rd party QA service providers to which audit and/or consultancy activities are outsourced. This includes providing training, managing financial information, and maintaining effective interfaces to ensure output meets expectations in content and timelines.
• Support development, improvement, and maintenance of the Astellas Quality System by signaling root causes of non-conformances related to the system and addressing observed gaps.
• Manage Quality Issues related to critical non-conformities, serious misconduct, and potential fraud. Lead proper corrective and preventive actions and ensure follow-up with effectiveness measures.
• Develop, analyze, and report relevant key performance indicator information.
• Manage GxP inspections, including communication with Regulatory authorities, inspection preparation, hosting, support of CAPA generation, and monitoring follow-up to ensure identified risks/non-conformances are addressed and mitigated.
• Develop and manage interfaces with QA departments of service providers to ensure QA oversight and risk mitigation.

Requirements

Required Qualifications

• 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 related areas (e.g., PV), as well as basic legal regulations.
• Very good interpersonal and communication skills.
• Ability to influence without authority.
• Project Management skills.
• Excellent attention to detail.
• Flexibility and adaptability.

Preferred Qualifications

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