Job Description

General Information

Job Advert Title
Manager, Quality Assurance, Technology & Data
Location
Poland
Function/Business Area
Information Technology
Employment Class
Permanent

Description

Manager, Quality Assurance, Technology & Data
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.
Astellas’ Global Capability Centres – Overview
Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Location and Working Environment
GCC POLAND: This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office
Astellas’ Responsible Flexibility Guidelines Statement - 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.
Purpose & Scope
• Responsible for managing and executing the Technology and Data Quality Assurance (TDQA) audit and validation oversight programs related to regional Astellas Digital X processes for computer systems, technology solutions, clinical and commercial systems, data integrity processes, and related process improvement initiatives within QA. • Provides operational management to drive consistent cGxP compliance and validation approaches to ensure compliance with Astellas standards, policies, and procedures. • Ensures compliance with global Electronic Records / Electronic signatures regulations and related cGxP regulatory requirements. • Responsible for managing the TDQA audit program related to audits of vendors, service providers, and internal processes in support of computerized system validations for new system implementations, system upgrades, change controls, and periodic reviews for computer systems. • Develops, facilitates, and implements process improvements and supports new technology initiatives as Astellas continually invests in new technology solutions and computerized systems.
Role and Responsibilities
• Responsible for operationally managing, coordinating, planning, and administering the TDQA program to oversee the computerized systems validation program, and ensuring reviews of computerized system validation documentation is completed to ensure compliance with Astellas policies and procedures. Reports status of validation projects to management. • Responsible for operational management, planning, and administration of the TDQA internal and vendor audit program related to computer software providers and computer related service providers utilized by Astellas. Responsible for scheduling and performing audits. Manages internal and external resources to perform audits. Reports status of audit program to management. Generates trend reports of audit findings for management reviews. • Interacts with functional teams to assist QA management to identify QA activities and resources necessary for review and support of project-related initiatives. Manage programs and resources necessary to support assigned projects. • Identifies, develops, 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 projects concurrently. Collaborates with key stakeholders and functional area customers across the Astellas organization for process improvement initiatives.
Continue: Role and Responsibilities
• Serves as QA representative on assigned project teams associated with software validation projects and process improvement initiatives to provide guidance, direction, and support regarding quality assurance and regulatory compliance, to resolve compliance issues, report to management, and to ensure completion of quality related action items. • Ensures and facilitates compliance with global Electronic Records / Electronic signatures regulations (e.g. 21 CFR Part 11). Provides quality and compliance guidance in areas of continuous improvement, innovation, and validation. Collaborates, advises and provides consultation on quality matters to individuals, study/core teams, and functional management teams across the Astellas organization. • Manages QA oversight of validation projects related to specific products to assure quality of output as well as compliance with standards, policies, procedures and regulations. • Develops tools to track and trend compliance metrics, validation activities and issues; and assures that Astellas systems and procedures comply with internal company (global, regional, and site) and external regulatory agency standards for compliance and validation. • Participates in the development of a comprehensive risk management process related to computerized systems validation activities within Astellas. • Authors, revises, and performs maintenance and administration of departmental quality documents (i.e., policies, SOPs, WPDs/WIs, STLs, etc.) as necessary. Conducts and coordinates validation, compliance, and quality training as needed.
Required Qualifications
• University degree required (Science or IT preferred) • Substantial years in the pharmaceutical industry, with a Quality Assurance experience. • Demonstrated leadership skills, including the ability to lead and manage projects and staff in a matrixed, global setting. • 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 0401022. • 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 facilitating and supporting regulatory agency inspections and third party audits pertaining to Data Integrity and Electronic Records/Electronic Signatures compliance with successful outcomes • Domestic and international travel of 5-10% is required.
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
• Impact • Innovation • Integrity • One Astellas • Accountability • Courage • Sense of Urgency • Outcome Focus
Benefits

Careers | Astellas

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.

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