Senior Manager, Pharmacovigilance Quality Assurance

Astellas; Markham; On-site; CAD 90,000 - 120,000; Full time

Job summary

A leading pharmaceutical company in Markham is seeking a Quality Assurance Manager to develop and maintain QA activities for pharmacovigilance. You will be responsible for conducting audits, liaising with health authorities, and ensuring compliance with national and international regulations. The ideal candidate has a strong background in life sciences and experience in pharmacovigilance QA. Competitive salary and growth opportunities offered.

Qualifications

• Experience in Pharmacovigilance QA activities.
• Proven track record in conducting audits.
• Ability to interpret health authority requirements.

Responsibilities

• Develop and maintain excellence in Pharmacovigilance QA activities.
• Conduct and report audits; liaise with customers on findings.
• Prepare Astellas entities for regulatory inspections.

Skills

Pharmacovigilance

Audit management

Regulatory compliance

Risk management

Education

Degree in Life Sciences or related field

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, conduct, and follow-up of Regulatory Inspections as directed.

• Execution of regional, cross-regional, and/or global multiple audit programs. This includes planning, conducting, and reporting 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, including:

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.
• Preparing Astellas entities and/or partners for regulatory inspections. Analyzing risks, proposing strategies for readiness, and managing the implementation of readiness programs across departments and territories to ensure a harmonized approach.
• Collaborating with PVQA leadership to identify outsourcing needs, select, manage, and evaluate 3rd party QA service providers. This includes providing training, managing financial information, and maintaining effective interfaces to meet expectations in content and timelines.
• Supporting the development, improvement, and maintenance of the Astellas Quality System by signaling root causes of non-conformances, addressing observed gaps, and ensuring systemic improvements.
• Managing quality issues related to critical non-conformities, misconduct, and potential fraud. Leading corrective and preventive actions, and ensuring follow-up with effectiveness measures.
• Developing, analyzing, and reporting key performance indicators.
• Managing GxP inspections, including communication with regulatory authorities, inspection preparation, hosting, CAPA support, and follow-up to address and mitigate risks/non-conformances.
• Developing and managing interfaces with QA departments of service providers to ensure QA oversight and risk mitigation.

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Quality Assurance Manager • Markham, ON, Canada