Manager, Quality Assurance, Technology & Data

at  WilsonHCG EMEA Ltd

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. Experience in these disciplines in the pharmaceutical industry.
• Regulated (FDA, EMA, MHLW, ISO, or other) computerized systems auditing experience in a pharmaceutical manufacturing or clinical development environment required. Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.
• Experience in developing and maintaining effective relationships with internal and external stakeholders for process improvement and issue resolution project teams. Collaborative skills to facilitate, manage, and work within project teams across departments and global organizations.
• 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.
• Excellent oral and written communication as well as presentation skills.

PREFERRED QUALIFICATIONS:

• Advanced degree in related disciplines.
• Previous experience in managing staff (contractors/consultants, full-time employees, or both).

EDUCATIONS/QUALIFICATIONS:

• Bachelor of Arts/ Bachelor of Science degree, or equivalent.

• 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. Report status of validation projects to management.
• Assist TDQA management to plan and manage internal and external resources to execute the TDQA validation oversight and audit programs. 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.
• 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, to resolve compliance issues, report to management, and to ensure completion of quality related action items.
• Ensure and facilitate compliance with global Electronic Records / Electronic signatures regulations (e.g., 21 CFR Part 11) and provide quality and compliance guidance in areas of continuous improvement, innovation, and validation.