Quality Assurance Laboratories Manager

Job title: QA Laboratories Manager
Department: Quality Assurance
Location: Hamble, Southampton, UK
Working Hours: Mon – Fri, 37.5 hours per week

A brighter future awaits you.

CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.

Scope:

Reporting directly to the Director QA/RC, the QA Laboratories Manager shall manage a team and ensure that all microbiological testing, autoclave validations, and materials testing are performed in accordance with Standard Operating Procedures and is compliant to applicable medical device regulations and ISO standards. This role is a business partner to manufacturing to ensure risk mitigation and appropriate actions are taken in a timely manner to ensure safe and compliant products are released and if required, for appropriate action to be recommended and taken.

Job Summary:

To manage the QA Laboratories Department and supervise the staff and workload of the Microbiology, and Autoclave department and to ensure compliance to regulatory requirements.

Essential Functions & Accountabilities:

• To manage the QA Laboratories departments of Microbiology, Autoclave, and Materials testing.
• To ensure all incoming materials are tested and accepted in accordance with our specifications and medical device regulations and standards including ISO13485, MDD, MDR, FDA QSR.
• To train Microbiology laboratory technicians ensuring all safety procedures are followed and that the required training is completed and recorded in a timely manner.
• The organisation of the workload to maintain the required level of routine monitoring and non-routine work to support Business Unit Projects.
• Validation of the test methods used in the laboratory and for other microbiologically related procedures such as the effectiveness of disinfection.
• As process owner for QA Laboratories and Microbiology, you will be required to support external audits by our notified bodies and health authorities.
• Processing and approval of Materials and Microbiology data in a timely manner to support the business production and release targets.
• Engineering Change Control: Lead and participate in the planning, preparation and execution of Engineering Changes Orders (ECO). In addition to provide support to Business unit projects with Risk Assessments and Engineering studies.
• Risk Management: Lead and participate on risk management teams.
• CAPA/NCR: Leading CAPA investigations and being involved in CAPA investigation teams, Completing CAPA Investigation reports and identifying / implementing Corrections, Corrective Actions and Preventive Actions as appropriate.Raising NCRs as required and reviewing NCRs to ensure relevant information is inputted and the correct product disposition is implemented.
• Understanding and applying the Six Sigma methodology including Define, Measure, Analyse, Improve and Control and participate on Six Sigma improvement projects.
• Use of aseptic technique for sampling of water, solution systems and un-autoclaved lenses and testing for bioburden.
• Testing the above according to relevant test methods, recording results and maintaining trend analysis.
• Performing environmental monitoring by laying settle plates, air sampling and monitoring of personnel in the wet production areas, recording results and maintaining trend analysis.
• To review the above results and investigate any identified areas of microbiological concern/contamination.
• Identification of isolates as required.
• Review of autoclave validation reports to ensure compliance to the respective Testing Monographs.
• Training of personnel in GMP and Introduction to Microbiology for working in Areas of Specified Environmental Cleanliness (ASECs) and sterilisation theory training in the absence of the Autoclave Validation Specialist.
• Responsible for setting departmental budget and reforecasting when required.
• Any other related duties connected with the Company’s business.

Travel Requirements

Local travel between UK sites is necessary, as required.
International travel to other CooperVision Sites - no more than between 5% = 3 weeks per year.

Knowledge, Skills and Abilities

Strategy

• Leverages professional expertise, external insights, customer & consumer needs to drive long range strategic thinking.
• Develops distinctive strategies to achieve and exceed expected performance through 
• process and our people.
• Shares a vision that inspires and engages people.
• Translates broad strategies into specific objectives, projects and action plans.
• Aligns the organization to understand how every role supports the strategic priorities.

Organisational Capability 

• Attracts and retains high calibre talent.
• Builds an inclusive, engaged culture that values diverse backgrounds and perspectives.
• Accurately appraises the strengths, weaknesses of others, providing coaching and 
• constructive feedback.
• Inspires, motivates and develops team to achieve exceptional outcomes.
• Develops a talent pipeline to ensure successors and talent pools to support future needs.

Results 

• Holds self and others accountable to achieve business results.
• Sponsors and directs change while maintaining operating effectiveness.
• Addresses root causes of issues and enable innovation and continuous improvement.
• Establishes stretch goals, monitors results and budget demonstrating financial acumen.
• Makes effective decisions by swiftly and critically considering risks, costs and benefits.

Impact 

• Builds strong internal and external relationships based on honesty, candor, trust and 
• respect.
• Understands the role/ interrelationships of each organizational function and demonstrates 
• enterprise-wide thinking.
• Effectively manages priorities collaboratively across organizational groups to achieve best 
• business outcome.
• Facilitates teamwork and honest communication across the organization.
• Listens, clarifies to understand intent, and skilfully shares information with others.
• Excellent communication skills, both verbal and written. Able to connect with clarity at all 
• levels within the organisation.

Mature Leadership

• Open to learning, feedback and realistically appraises their own strengths and weaknesses.
• Maintains confidence, resilience and agility when challenged or in the face of adversity.
• Addresses issues directly with a fair and balanced approach with the company’s best 
• interests in mind.
• Models’ high integrity and lives the organizational values.
• Recognizes high performance.
• Effective delegation and achievement of results through other individuals and teams.

Work Environment

The post operates primarily in an office environment however the role will require entry to Areas of Specified Environmental Cleanliness (ASEC) to assess processes and changes and also the Microbiology Laboratory when required to cover for the Microbiology Technicians.

Experience and Education

• Minimum five years in the contact lens or medical device industry
• Minimum of ten years in a Microbiology Laboratory setting.
• Experience in medical device industry, group direct reporting, and laboratory investigations.
• Experience in laboratory equipment (HPLC, GC, TOC, IR, UV, Incubators, autoclave, air sampler, etc.).
• Experience in Quality Systems audits.
• Minimum of seven years in a Management/Supervisory experience.
• Minimum Batchelor of Science degree in Microbiology or Biological Sciences or related discipline and proven Microbiology background in Medical Device sector.

What we offer:

You’ll receive competitive compensation and a fantastic benefits package including bonus, private medical insurance, 25 days holiday, pension scheme, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!

We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.

We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision

What you can expect:

As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.

If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1to view all other opportunities.

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