Quality Assurance Manager
A trail blazing and fast paced pharmaceutical company are in search for a Quality Assurance Manager. This organisation is dedicated to developing new products, this role is for an innovative QA Manager who will thrive on making things happen.
- Develop and improve quality management systems for the clinical interventional and non-interventional research, based on current best practices in industry;
- Provide leadership and guidance during EMA and FDA health authorities inspections; Prepare and organise responses to regulatory agencies partners
- Develop and implement tools for quality risk management that can be applied to different aspects of
- pharmaceutical quality.
- Ensure the high level of the vendor selection, qualification and monitoring process
- Manage and trend the deviation process while ensuring that a thorough investigation report is completed in a timely manner using proven root cause analysis tools.
- Manage commitments to ensure timely completion of the outlined tasks and effectiveness.
- Promote a culture that supports continuous improvement through active communication and functional area participation.
- Investigate and address identified compliance and quality issues and develop solutions to correct known and potential compliance and quality concerns.
- Support QA activities may also include conducting international audits, maintaining quality databases and performing trend analysis, reporting metrics, performing quality and compliance training (as needed), developing and updating SOPs, specifications, policies and/or other quality documents as needed.
Skills and Requirements
- 10 or more years' experience in a technical role in quality assurance, manufacturing, analytical testing or engineering with at least 5 years in a related management role
- Significant background acquired in pharmaceutical company
- Significant experience of EMA and FDA inspections
- BS in Engineering, Chemistry, Biological Sciences or related field with an education or training in cell culture and gene therapy a plus
- ASQ Auditor certification, ASQ Quality Engineer certification preferred
- Fluent in English
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.