Quality Assurance Associate

**Astellas Canada - People Operations Partner**

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.**

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.**

Astellas Pharma Canada (APCA) is currently searching for a Quality Assurance Associate reporting to Head, Quality Assurance, Established Mid-Sized Markets Canada.

**Description**:
Independently completes standard quality assurance activities in the affiliate. The position supports the Responsible Person, where applicable, and the QA Lead to meet his/her Responsibilities and Accountabilities.
- This is a 1yr fixed-term contractual position.

**Essential Job Duties**:
Performs, records and processes all standard, non-complex activities that are governed by Good Distribution Practise Guidelines (GDP Guidelines) as defined in the (global) Quality Management System (for example on QA oversight of Product Storage and Distribution, nonconformance management, product complaint handling, change control, supplier management and annual product review) and implements improvements to correct inefficiencies and non-conformances

Supports with inspection management for the wholesale dealer license (or equivalent license), specifically during inspections and recalls

Represents Affiliate QA in recurrent, non-complex local and global project teams, such as workflow training, onboarding training

Performs QA acceptance and/or triage, but not final acceptance of all QA records (apart from product returns)

Acts as a role model for the Quality Culture in the affiliate

This position will be hybrid, spending 50% in office with 50% of time working from home

**Required Qualifications**:
5+ years' relevant experience in a comparable role in the pharmaceutical industry preferred

Experience of implementation and understanding of GDP, GMP and Quality Management Systems preferred

Fluency in written and spoken English

Good organizational, coordination, presentation and communications skills

**Preferred Qualifications**:
Experience with Trackwise (Digital), Veeva and SAP systems

Experience with handling regulatory interfaces such as inspections and audits

**Working Environment**:
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

**Additional Information**

Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.

LI-TR1

Category Affiliate & Supply Chain QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans