Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses portfolio. In 2017, Johnson & Johnson invested further in eye health by expanding into cataract surgery, laser refractive surgery (LASIK) and consumer eye health. Serving more than 60 million patients a day across 103 countries, Johnson & Johnson Vision is committed to helping more people in more places improve or restore their sight. Dual headquartered in Jacksonville, Florida, and Santa Ana, California, Johnson & Johnson Vision has more than 8,400 employees worldwide!
We now have an opportunity for a Quality Director to join our site leadership team to develop and implement strategic plans to ensure the ongoing business growth and success of the site at Groningen.
The Quality Leader will be the responsible Management Representative for the Quality System at the Groningen site and will define documents, implement and maintain a fully integrated Quality Management System for manufacturing operations.
The Quality Director will lead the quality function and ensure products meet required specifications and conform to all Johnson & Johnson standards and all external regulatory requirements and will also lead all external and internal audits.
Reporting to the Senior Director of Quality Operations Surgical Vision the Quality Director will:
Attract, recruit, train new team members; planning, advising work; appraising performance; rewarding and focusing employees; addressing complaints and resolving problems.
Lead, the overall direction and performance of the Quality functions.
Develop and lead the Quality team and programs in areas of Sterility Assurance, Change Control, Risk Management; Quality Assurance/Compliance, CAPA, Microbiology, Complaint Handling, Chemical and QC Laboratories areas.
Develop, implement, and coordinate quality assurance program to ensure that all released products are safe, effective and of the highest quality and ensures compliance to regulatory requirements.
Lead/support all internal and external audits (e.g. FDA, Notified Body, J&J Enterprise) & promotes the awareness of regulatory requirements throughout the site / organization.
Implement Franchise and Global J&J quality policies, strategies, best practices & initiatives.
Ensure the Groningen site is in a continued state of compliance using: internal audits, external audits, self-audits, and evaluation of other inputs including complaint vigilance.
Establish & maintain global relationships with partnering organizations and regulatory bodies.
Lead cross‐functional teams and provide subject matter expertise to other departments working collaboratively with Senior Leaders across the organisation.
Coordinates problem solving strategies to meet changing market opportunities.
Responsible for Quality Department finance budget and maintains operating costs and headcount in line with best practice.
Critical member of Groningen site leadership team and is a critical influencer in site growth and expansion.
Partners with other functions such as Operations and Engineering to drive efficiencies and lower operating expense while maintaining or improving quality and compliance.
Education and Experience Required:
Degree qualification in appropriate field – science, engineering or technology.
Minimum of 8 years of experience working in a medical device, Pharmaceutical or health authority regulated manufacturing company, either within a Quality or Production function, of which at least 4 - 5 years in a Quality senior/managerial position.
Post Graduate qualification in Quality related subject area.
Experience in the use of statistical techniques for Quality Operations.
Other Skills and Attributes:
Detailed knowledge of International Regulatory requirements (e.g. EU MDR, US FDA etc).
Excellent organizational, interpersonal, written and oral communication skills required.
YOU will enjoy multi-tasking, have a strong ability to prioritize workflow and facilitate and resolve cross functional activities and issues.
Passion for facilitating meetings and speaking publicly to all levels across within a global organisation.
YOU will be a natural leader and problem solver with a strong strategic outlook who fosters innovative and develops forward thinking techniques.
The successful candidate will receive an attractive re-numeration package with a Bonus, Health insurance, Pension, Fitness & Culture Allowance, Employee Assistance Program and many more!
AMO Groningen BV (8358) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies