Purpose & Scope - Responsible for executing the Technology & Data Quality Assurance oversight of computer system validations to assure and drive compliance with Astellas policies and procedures by reviewing validation documents and performing vendor and internal audits in support of computerized system validations for new system implementations, system upgrades, change controls, and periodic reviews for Astellas systems.
- Responsible for facilitating and driving compliance related process improvement initiatives related to regulatory compliance of computer systems and related business processes.
- Ensures consistent cGxP compliance and validation approaches to ensure compliance with global Astellas standards, policies, and procedures.
- Develops, facilitates, and implements process improvements and supports new technology initiatives for Astellas.
- Contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5 year strategic plan.
Role and Responsibilities - Responsible for planning and executing the TDQA program to oversee the computerized systems validation program, including reviewing and approving computerized system validation documentation for compliance with Astellas policies and procedures. Reports status of validation projects to management.
- Responsible for executing the TDQA internal and vendor audit program to assess Astellas internal processes and computer software vendors and computer related service providers utilized by Astellas business functions. Responsible for scheduling and performing audits, reporting audit findings, and working to ensure appropriate audit response and corrective actions.
- Interacts with project teams to assist QA management to identify QA activities and resources necessary for review and support of project-related initiatives.
- Facilitates and manages process improvement initiatives related to electronic system development life cycles, validation processes, IT systems/processes, data integrity control processes, and regulatory compliance assurance processes throughout Astellas.
- Manages multiple assigned projects concurrently. Collaborates with key stakeholders and functional area customers across the Astellas organization (local and global) for process improvement initiatives.
- Serves as TDQA representative on assigned project teams associated with software validation projects and process improvement initiatives to provide support regarding quality assurance and regulatory compliance, to communicate compliance issues to management, and to complete quality related action items.
- Provides QA oversight of assigned projects to assure quality of output as well as compliance with standards, policies, procedures and regulations, including the global Electronic Records / Electronic signatures regulations (e.g., 21 CFR Part 11).
- Develops and utilizes tools to track and trend compliance metrics, validation activities, and quality related issues; to ensure that Astellas systems and procedures comply with internal company (global, regional, and site) and external regulatory agency standards for compliance and validation. Reports project and program status to QA management.
- Participates in the development of a comprehensive risk management process and risk based approaches related to computerized system validation activities within GMD.
- Authors, revises, and performs maintenance and administration of departmental controlled documents (i.e., policies, SOPs, WPDs/WIs, Forms, etc.) as necessary. Conducts and coordinates validation, compliance, and quality training as needed.
Required Qualifications - University degree required (Science or IT preferred).
- Minimum of 3 years in the pharmaceutical industry, preferably within Quality Assurance.
- Demonstrated knowledge of global industry standards and regulatory requirements for, software development, computer system validation, Electronic Records / Electronic Signatures regulations, Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP), and related GxP regulations in the global regulatory environment including GAMP5, 21 CFR Part 11, EU Annex 11, and Japan Notice [redacted].
- Demonstrated knowledge of quality assurance of computer system validation process management in a pharmaceutical manufacturing and clinical development environment.
- Demonstrated knowledge of development, management, and execution of internal and vendor auditing processes, audit reporting systems, and audit/CAPA management.
- Demonstrated experience in supporting regulatory agency inspections and third party audits pertaining to Data Integrity and Electronic Records/Electronic Signatures compliance with successful outcomes.
- Demonstrated experience in supporting process improvement and harmonization activities, especially in the areas of Data Integrity, computing environment development, validation, control, and maintenance.
- Effective written and oral communication and interpersonal skills, facilitation and influencing skills with an ability to interface globally across multiple departments and across various levels of management with Astellas and with external stakeholders.
- Domestic and international travel of 5-10% is required.
Location and Working Environment- This position is based in Markham, Ontario. Remote work from anywhere in Canada, except for Quebec is available.
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.
Salary Range$96,180 - $137,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
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
