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Quality Assurance Manager
2 maanden geleden
We are seeking a highly skilled Quality Assurance Manager to join our team at WilsonHCG EMEA Ltd. in the United Kingdom and the Netherlands. As a key member of our organization, you will be responsible for leading and executing audit and validation programs for our Information Systems.
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 our 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 our organization.
- 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.
Requirements:
- 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.
- 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.
- Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration.
What We Offer:
- A challenging and diversified job in an international setting
- Opportunity and support for continuous development
- Inspiring work climate
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.