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You will be updated with latest job alerts via emailThe microbiology manager is responsible for the oversight of microbiology laboratory activities and for management of the microbiology team. This role involves close collaboration with new product development project teams to drive the successful development of new products and maintaining quality compliance and safety standards within all microbiology team activities.
Key Responsibilities
To act as a technical expert on behalf of the organisation by providing advice guidance and expertise on microbiological issues.
Actively manage the microbiology laboratory team including effective engagement communication recruitment and employee development.
Responsible for managing the microbiology testing programme. Ensure all microbiological 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.
Responsible for microbiology test method validation and equipment validation requirements in accordance with Convatecs procedures.
To manage and ensure appropriate allocation of laboratory resources and drive ontime completion of team activities.
Accountable for software validation activities for the deployment of microbiology laboratory equipment software packages.
Accountable for Microbiology Laboratory safety including the timely preparation and approval of all required laboratory safety deliverables.
Lead/manage continuous improvement initiatives within microbiology systems.
To lead/manage microbiology laboratory related nonconformances CAPAs planned deviations change controls OOSs as required ensuring corrective actions are fully implemented to address root causes etc.
Perform other activities as and when required to support laboratory operations.
Skills & Experience
Preferably 7 years experience working 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.
A drive for excellence and high attention to detail.
Ability to lead motivate develop and influence a team.
Competent to provide technical support and advice to other Convatec functions and franchises; serves on various teams as a functional leader.
Strategic thinking capabilities evidenced by successful delivery of projects in a previous laboratory role.
Strong organisational skills and the ability to manage business complexity and multiple priorities at one time.
Ability to network internally and externally and stay engaged via industry best practices and standards.
Good interpersonal skills and ability to form effective working relationships
Qualifications/Education:
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 FDA 21 CFR part 820 and GMP Guidelines and Regulations.
Possess a flair for problem solving identifying inefficiencies and implementing solutions.
Microsoft Office skills are essential.
Working knowledge of statistics and software packages are preferable.
Team:
510 direct reports
Working Conditions
Hybrid working model Visit the GDC site x3 per week to collaborate with functional teams and build strong working relationships.
Our products make a big difference every day. So will your contribution. The work you do will mean more because itll make things better for your team our business or our customers lives. Itll inspire you to deliver to your very best. And well be right behind you when you do.
This is a challenge more worthwhile.
This is work thatll move you.
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race religion creed color national origin nationality citizenship ancestry sex age marital status physical or mental disability affectional or sexual orientation gender identity military or veteran status genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec employee
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Required Experience:
Manager
Full-Time