Quality Systems Manager
Il y a 6 mois
Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a **QA Manager - Quality Systems (M/F/X). **You will be a member of our Quality team overseeing the Quality Systems (QS) processes, based in Geel, Belgium.
J&J Innovative Medicine Supply Chain in Geel serves as Centre of Excellence for the development and manufacturing of SM-APIs and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. J&J Innovative Medicine Supply Chain Quality (IMSCQ) supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-APIs and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.
**As QA Manager - Quality Systems, you will be a Subject Matter Expert of processes, such as change control, non-conformance management, document management, records management, training,You will drive the implementation at our site and ensure adherence to the Quality System. You report directly to the Senior QA Manager.**
**In this role you are responsible for:
- Establishing and maintain strong working relationships with your global Quality Systems partners as well as your local Quality and Supply Chain colleagues.
- Acting as QA Point of Contact for our site ensuring QS are appropriately implemented and applied.
- Acting as local Process Owner for Quality System processes by:
Acting as local Subject Matter Expert, including ensuring GMP documentation is in place and training provided ensuring compliance with global regulations and J&J quality requirements
Providing support to local users and quality approvers
Driving the site to continuously strengthen related skills across the entire organization
Evaluating trends and defining appropriate actions
Defining, following up and concluding corrective and preventive actions related to the QS processes
Leading the periodic governance meeting to guarantee quality oversight, including escalation to senior management when risks are identified
- Ensuring that quality records such as change controls, non-conformances and CAPAs are timely and accurately handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.
- With focus on Quality processes, developing and fostering an environment of innovative thinking through e.g. benchmark and training. Continuously challenging the status quo by finding opportunities for continuous improvement.
- Leading and participating in continuous improvement initiatives on the QS processes.
- Acting as spokesperson during Health Authority inspections and customer audits.
**Qualifications**:
- Master Scientific degree with a technical specialization in analytics / chemistry / biotechnology / pharmaceutical sciences (or equivalent through experience)
- In-depth knowledge of cGMP (domestic & international), ICH guidelines, policies, standards and procedures
- Experience with Data Analysis and continuous improvement methodologies is an asset.
- Experience in Chemical and/or Pharmaceutical Quality Control and/or Quality Assurance
- Experience in people leadership.
- You work accurately and proactively seek solutions.
- You have the necessary communication and interpersonal skills.
- You speak and write Dutch and English fluently.
- Strong analytical thinking skills and able to work in a flexible way under time pressure in local and global teams. Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.
**_Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. _
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