QA Manager
About the role
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QA Manager
- Provide Quality validation leadership support as the Quality – IT liaison for computer system assessments, validation and change control, and provide effective Quality support at all applicable support points of the Software Development Lifecycle (SDLC).
- Lead and perform quality assessments and vendor audits of IT vendors, to ensure quality oversight and routine periodic review of vendor compliance performance.
- Contribute to the execution of configuration, validation, deployment and management of ICON IT System. Collaborating with Business Operations, IT and other partners to ensure effective delivery.
- Perform timely and effective QA review of validation documentation such as SOPs, Master Validation Plans, Traceability Matrices, Testing deliverables, and Data Migration Plans.
- Lead and coordinate efforts for the identification, development, implementation of IT programs, policies and procedures in support of ICON’s GXP programs as primary QA IT contact along with other Quality and cross-functional members
- Actively provide suggestions for solutions to process issues, and collaborate with appropriate partners to drive efficiency.
- Provide timely updates on projects and deliverables to Quality Management and any other functions that support IT validation project deliverables.
- Provide GXP subject matter expertise as needed – perform critical assessments/data and document reviews, conduct audits, develop SOPs and role model investigation/problem solving skills.
- Work in collaboration with Global Quality management to support IT audits (internal and external) to assure adherence to company SOPs, and any applicable regulatory requirements
- Identify and demonstrate standard methodologies across the enterprise for ICON Quality Systems.
- Contribute the ensuring effective budgetary control within the department.
- A minimum of 5 years QA (or equivalent) experience in the pharmaceutical or CRO industry, with some previous management/supervisor responsibilities preferred.
- Bachelor’s Degree in related field is required while an advanced degree is preferred
- In depth understanding of concepts, theories and principles in own discipline with some knowledge of other disciplines e.g. data management, biostatistics, business development, project management etc.
- People management skills, you will enjoy guiding and developing your team.
- Change management skills with the ability to secure staff dedication to change.
- In depth knowledge and understanding of drug development and the clinical trial process
- Highly developed problem solving skills, and the ability resolve difficult situations. Team building and leadership skills.
- Demonstrated training skills, including the ability to give constructive feedback.
- Ability to gain the confidence and cooperation of colleagues.
- Cost consciousness, with good commercial awareness and customer focus.
- Knowledge of regulations, hosting audits, preparing audit reports, corrective and preventative actions (CAPA) and complaint handling.
- You will enjoy working cross functionally and a global level.
- Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver’s license.
Application process
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