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Manager, Quality Document Management
2 weeks ago
**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.**
**Description**
**Support QA Document Records Program**: Help set up and manage a Quality Assurance (QA) document records program. This involves systematically assessing, reviewing, controlling, distributing, retaining, and archiving records from customers and stakeholders.
**Manage QA Document Life Cycle**: Identify and support processes for managing the lifecycle of QA documents and records. This includes tracking system administration, filing, archiving, and retention.
**Ensure Regulatory Compliance**: Ensure that all documents and their retention meet global regulatory requirements, such as cGMP, GLP, GCP, and electronic records and signatures.
**Lead QA Improvements**: Lead continuous improvement projects for QA documentation processes that may impact multiple departments.
**Essential Job Duties**:
Maintains a central repository for all QA controlled documentation and coordinates processes for documents received from internal customers, Astellas entities and external companies. Performs quality risk assessment and ensures compliance with established retention schedules. Supports the managing, assigning, and prioritizing the document distribution activities to the appropriate QA personnel.
Creates procedures required for the documentation processes within QA to ensure compliance with global and regulatory standards for a modern quality system. Supports the establishment and determination of record retention for QA documents/records, ensuring compliance with established regulations and procedures.
Facilitates the effective processing of all critical QA documents/records to ensure they are maintained in an organized and retrievable state (manual or electronic) for accountability and access for any regulatory body. Assures compliance with SOPs and regulatory requirements.
Utilizes technical skills and tools to effectively identify issues, evaluate risk and facilitate appropriate solutions to management.
Collaborates with cross functional departments and external entities to ensure proper tracking, review and approval of quality documents. Trends and generates Quality metrics for QA Management review.
Effectively researches and supports continuous improvement in QA processes or systems related to document management and which can impact other departments.
Conducts orientation and in-house, site-specific training on Quality documentation SOPs and relevant QA systems/ processes. Develops, maintains, and deliver training materials.
QA notification and enhancements of the department’s knowledge of quality systems and strategies.
Supports the establishment/implementation of Quality system documents and regional quality standards, as needed.
Performs other duties as assigned or special projects as needed.
**Required Qualifications**
Bachelor’s degree or equivalent with 3 years of industry experience.
Must demonstrate effective communication, writing and interpersonal skills and the ability to interface across multiple departments and external stakeholders.
Detailed knowledge of GXP regulations, other quality principles and applies current interpretations/trends to Quality documentation and record control.
Ability to generate SOPs related to critical QA processes.
Must demonstrate ability to manage projects independently, with limite
