Quality Assurance Manager

1 week geleden

Leiden, Zuid-Holland, Nederland WilsonHCG EMEA Ltd. Voltijd
About Astellas

Astellas is a progressive health partner that delivers value and outcomes where needed. We pursue innovative science, focusing on areas of greatest potential, and develop solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors, and healthcare professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.

The Opportunity

As a Manager, QA Technology & Data, you will lead and execute audit and validation programs for Astellas' Information Systems. This includes ensuring compliance with company standards, policies, and global regulations for electronic records and computerized systems.

You will manage audits of vendors, service providers, and internal processes, support new technology initiatives, and drive process improvements. Additionally, you will help maintain compliance with Good Practice (cGxP) standards and contribute to Astellas' long-term QA strategy.

Key Responsibilities
  • Manage, coordinate, plan, and administrate the TDQA program to oversee the computerized systems validation program and ensure reviews of computerized system validation documentation is completed to ensure compliance with Astellas policies and procedures.
  • Assist TDQA management to plan and manage internal and external resources to execute the TDQA validation oversight and audit programs.
  • Identify, develop, facilitate, and manage process improvement initiatives that relate to electronic system development life cycles, validation processes, IT systems/processes, data integrity control processes, and regulatory compliance assurance processes throughout Astellas.
  • Serve 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.
Essential Knowledge & Experience
  • In-depth knowledge of GxP regulations and computerized systems in GxP regulated environments, preferably for pharmaceuticals, relating to product development, combined with broad knowledge of quality principals and industry trends.
  • In-depth knowledge of global industry standards and regulatory requirements for software development, computer system validation, and Electronic Records and Electronic Signatures regulations.
  • Regulated (FDA, EMA, MHLW, ISO, or other) computerized systems auditing experience in a pharmaceutical manufacturing or clinical development environment required.
  • Experience in developing and maintaining effective relationships with internal and external stakeholders for process improvement and issue resolution project teams.
Preferred Qualifications
  • Advanced degree in related disciplines.
  • Previous experience in managing staff (contractors/consultants, full-time employees, or both).
We Offer
  • A challenging and diversified job in an international setting.
  • Opportunity and support for continuous development.
  • Inspiring work climate.

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