**Job Summary:**
We are seeking a highly experienced laboratory management specialist to oversee laboratory activities, manage the microbiology team, and ensure compliance with regulatory requirements.
Key Responsibilities:
* Provide technical leadership and support on microbiological issues.
* Manage the microbiology laboratory team, including recruitment, training, and employee development.
* Responsible for managing the microbiology testing program, ensuring all testing methods and validation exercises reflect applicable regulations/guidelines and meet industry best practice.
* Accountable for meeting targeted KPIs and monitoring team performance; maintain and update all assigned systems and databases.
* Provides regular management reports as required.
Requirements:
* 7+ years' experience in the Medical Device/Pharmaceutical Industry within a R&D/product development role.
* Experience with FDA 510k submissions and test methods for microbiological claims.
* Strong background in microbiology, significant experience, track record, and knowledge within Microbiology or a Laboratory Management environment.
* Drive for excellence and high attention to detail.
* Leadership and team management skills.
Education and Qualifications:
* Degree level in a biological science discipline, preferably in microbiology.
* Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2015) and GMP Guidelines and Regulations.