Manager, Quality Assurance

We are looking for an experienced Quality Assurance Manager to join our specialist team, to help support our business areas with corporate systems compliance, complex architecture and interoperability as well as data governance and data integrity.

As a Quality Assurance Manager your role will involve:

• Providing cross-functional Quality Assurance expertise, supporting all areas of Data Integrity and Technology Compliance.
• Responsible for the oversight of the Computerized Systems Validation (CSV) review process and qualification deliverables to ensure documentation supports a compliant state.
• Supporting efforts for standardization and advancement of validation / qualification methodologies in support of software, equipment with software and medical devices used in a clinical setting. 
• Responsible for analysing technology related risks and the creation, execution and oversight of Technology Audit schedules (Internal and Vendor).
• Supporting technology focused sponsor audits and inspections.
• Providing guidance to technology and information management groups to ensure the business understands applicability of associated published regulatory guidance or regulations concerning GCP, GLP, GMP, 21CFR Part 11, and Annex 11.
• Supporting training activities focused on advancing Systems Compliance SMEs across Quality and Compliance.
• Developing and fostering positive relationships with business unit customers to ensure a common understanding, approach and appreciation for computerized systems validation (CSV) and technical auditing, with focus on Data Integrity and system integration.
  

As a Quality Assurance Manager you will need:

• Degree level education
• Experience specific to the application or support of software validation and compliance efforts. 
• Experience in QA, with GxP auditing, Data Integrity and CSV
• An understanding of validation and qualification strategies for regulated systems including software and medical devices used in clinical settings
• Demonstrated strength in agile working principles, methodologies, and team structures
• Expert knowledge with audit or inspection management
• Ability to travel as needed to vendor and/or internal sites