Manager, Quality Document Management

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

Administer the QA document control program on an Electronic Document Management System

Role and Responsibilities

• Administer the QA document control program on an Electronic Document Management System
• Establish metrics to optimize quality and customer satisfaction
• Maintain a central repository for QA-controlled documentation and coordinate processes for documents from internal customers, Astellas entities, and external companies.
• Perform quality risk assessments and ensure compliance with retention schedules.
• Create procedures for documentation processes to comply with global regulatory standards.
• Facilitate the processing of QA documents/records to ensure they are organized and retrievable
• Assure compliance with SOPs and regulatory requirements.
• Collaborate cross-functionally and with external entities to track, review, and approve quality documents.

Required Qualifications

• Bachelor’s degree (STEM preferable) or equivalent experience
• Knowledge of English allowing for fluent written and spoken communication
• 3+ years of industry experience in Pharma/Biopharma, QA or Medical Devices
• Expertise in Electronic Document Management System (Veeva Vault Quality Docs preferable but not essential).
• Technical writing and documentation skills
• Proficient knowledge of MS Office
• Quality Management Systems (QMS) experience
• Strong communication, writing, and interpersonal skills
• Detailed knowledge of GxP regulations, quality principles, and the ability to apply current interpretations/trends to documentation and record control.
• Cross-boundary collaboration and stakeholder influencing
• Critical thinking and detail orientation

Preferred Qualifications

Expertise in Electronic Document Management System (Veeva Vault Quality Docs preferable but not essential).

Location and Working Environment

• This position is based in Markham, Ontario, Canada.

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.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency.  We are outcome focused and consistently take accountability for our personal contribution.

Salary Range: $80,920-$115,600 CAD annually per year (final compensation will be determined based on a variety of factors, including but not limited to proficiency levels and organizational equity considerations)

*The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time and national holidays
• Registered Retirement Savings Plan Program (RRSP)
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Wellness programs 

Astellas may use artificial intelligence-enabled tools at various stages of the recruitment and selection process.

Additional Information

Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.

No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.