Quality Systems Leader

Working hours: Monday – Friday 37.5 hours per week - 5 days a week on site – 1 day a week travel to our MountPark site in Southampton.

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.

Job summary – What to expect:

We have an exciting opportunity for a Quality Systems Leader to join our team at our site in Fareham. This position will have 3 direct reports and cover a wide breadth of the quality system including Auditing, Non-conformance, Complaint Handling, Change Management, and eQMS administration. You will be responsible for Document Control and Quality System Specialists, to deliver process and quality improvements and resolve quality issues for CooperVision operations in the UK Packaging & Distribution site. You will also be monitoring and improving the effectiveness of the Quality Management System through deployment of CAPA review board and KPIs, management of internal audit program and external audit activities. You will be responsible for generating awareness of quality assurance and quality system requirements across the site and lead/participate in programs/cross-functional teams to improve compliance and reduce regulatory and product quality risk.

Other responsibilities include:

• Assist with the development of team members, including assessing organizational capabilities and leading the development strategy, raising capacity and competency to support the continued growth of the organization.
• Provide guidance to CAPA teams through use of the CAPA process, and assists with implementing mechanisms for monitoring their timeliness and effectiveness.
• Define, prioritize, and implement effective Key Process Indicators (KPIs) for monitoring performance of the QMS, ensuring processes in place for communicating trends to the business, acting on trends and facilitating cross-functional review/actions.
• Regularly provide status and updates to Management regarding state of Packaging and Distribution QMS data and continuous improvement projects. This will include reports / data / charts / etc. for QA management monthly-reporting.
• Provide support in the investigation and documentation of Distribution Quality Feedbacks (QFBs), Non-conformance Reports (NCRs), and Service Non-conformances (SNCs).
• Manage the site internal audit program, ensuring audits are scheduled, performed, reported out, and cover areas of highest product and regulatory risk. Perform internal and supplier audits.
• Manage development and training of internal auditors.
• Lead external audit preparedness activities to ensure the site is ‘ever audit ready’, with audit support in place and site leadership/functions aware of responsibilities.
• Identify and implement with cross-functional team support improvements to eQMS tools & workflows.
• Act as the QA representative and participate with cross functional teams on significant Packaging and Distribution projects.
• Provide support to Engineering Change Orders, risk assessments, and validations for systems-related projects.
• Ensure that the QMS document change process is administered correctly in a timely manner including global document implementation.
• Manage the change analyst process for West Henrietta with other team members for support.
• Assist with process audits to verify conformance with standard operating procedures. This may include revising and / or creating SOPs as needed.
• Applies knowledge of Good Manufacturing Practices (GMP) regulations and industry standards as well as ISO general guidelines.

About you:

We are looking for someone with the following experience:

• Substantial experience with Quality Assurance or Regulatory Affairs is essential.
• Medical Device industry experience preferred but would consider Pharmaceutical or other regulated industries.
• Demonstrated success leading continuous improvement in a cross functional business unit structure including through structured CAPAs and other QMS tools.
• Ability to build credible inter-departmental relationships.
• Well organized and detail oriented, strong data entry and analysis.
• Excellent analytical and problem-solving skills, with strong attention to detail.
• Ability to drill down to the root cause.
• Ability to effectively prioritize and execute tasks, and meet project deadlines in a fast-paced environment.
• Possess skills to utilize the concept of continuous improvement, change management and employee teams.
• Knowledge of Quality Assurance regulations and methodologies, including Good Documentation Practices.
• Ability to enforce standards (QSR, CVI, and standardize global processes).
• Qualified auditor.
• Knowledge and experience using ISO14971 Risk Management for Medical Devices would be highly desirable.

What we offer:

You’ll receive competitive compensation and a fantastic benefits package including; 25 days holiday, private medical, pension scheme, healthcare cover, life assurance, 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.