IBA is at the forefront of technology in the fight against cancer! IBA delivers solutions of a unique precision in the fields of cancer diagnosis and therapy. In no more than 20 years we have developed unrivalled expertise in the design and installation of cyclotrons, and in the production and distribution of radiopharmaceutical tracers, used every day in hospitals around the world to quickly and accurately detect cancer, neurological and cardiac diseases.
In the field of cancer therapy we have developed radiotherapy solutions and dosimetry equipment to treat cancer with the greatest accuracy. Finally, we also design electron accelerators and high power X-Ray solutions used in many industries to sterilize medical devices, to cold pasteurize food products and to improve polymer properties.
Quality Manager - MAS PT product installation Job Description
As Regulatory and Quality Manager, your main tasks will be to:
- Establish the yearly QA management objectives and the associated implementation action plans
- Periodic QA Objectives implementation review of the yearly action plans
- Monitor process progress measurement (KPIs) and alert management on deviations
- Coach & support to the stakeholders (site management, project management) when needed and ensure necessary follow-up
- Oversee the timely production of project's quality deliverables, and monitor progress and represent Quality during the R&D and ESD Management reviews
- Perform complex operational projects Verification & Validation management as necessary
As Regulatory and Quality Manager, your essential duties and responsibilities will be to: - Accountable for product and project conformity and ensure the continuous Regulatory Compliance of the RP and Ind products for each Region where installation is performed
- Manage the RP and Ind products Factory Quality Assurance (QA) and Site installation QA and participate to coordinated management meetings with R&D and ESD Department Management
- Responsible for Offers and contracts reviews for product Quality and Regulatory compliance
- Responsible for compliance to local authorization for product installation and testing
- Responsible for QA plan writing together with her/his team QA V&V Specialist(s)
- Accountable for compliance of testing: DQ,OQ & PQ and cross-checks of IQ test procedures and reports together with her/his team QA V&V Specialist(s)
- Responsible for Project QA plan follow-up (progress matrix) together with her/his team QA V&V Specialist(s)
- Perform Site installation IPQC as needed following KPI and trend drifts
- Accountable for completion of e-maint deployment in coordination with Sites
- Accountable for concession compliance (waivers and deviation review, release under concession ...)
- Responsible for System technical construction file (TCF) maintenance together with her/his team QA V&V Specialist(s)
- Responsible for Site delivery note provision including for new R&D features together with her/his team QA V&V Specialist(s)
Quality Manager - MAS PT product installation Job Requirements
Profile Education and Professional Experience:
- MS in science: Radio-Pharmacy, Bio-Chemistry, Physics or Mechanical/Electrical engineering
- At least 5 years experience in similar function
- Previous experience in people management
- International experience desirable
- Experience in similar position of large scale industrial equipment
Best Practices Experience: - Knowledge of ISO 9001, ISO 13485, ISO 14971, ISO 11137, Radio-Pharmaceutical GMP( FDA 21CFR212), European Pharmaceutical GMP- 2005_10_03_GMP Part II
- Knowledgeable in the following is a plus:
- European Directives for: Low voltage equipment , Electromagnetic compatibility, Pressure equipment, protection against dangers from ionizing radiation, Reach and RoHS, Medical devices
- ISPE guidelines for Pharmaceutical process validations
- Aseptic process control for the manufacturing of injectable drugs for human use
Behavioral Characteristics: - Supervising, Planning and Organizing
- Communicating and Persuading
- Working as a Team in a Collaborative manner and “open minded”
- Achieving Results
- Flexible and Adaptive for Meeting Customer Expectations
- Able to Manage under constraints when contingency plans are to be implemented. This should be done by applying situational leadership and Assertive communication good practices.
Other Skills: - Language: English (fluent spoken & written);
- Computer:
- General Knowledge of Microsoft products such as Microsoft Project, Excel, Word, Access, Outlook, Power Point
- SAP basic knowledge
CompanyIBA : opening new ways in the fight against cancer.
IBA develops, manufactures and supports medical devices and software solutions for cancer treatment by proton beam therapy, for cancer diagnosis and for patient quality assurance (Dosimetry). In addition, the company partners with healthcare leaders to provide cancer clinics and academic health centers with a fully-integrated approach of the patient flow. Offer IBA offers you the opportunity to realize great achievements in the fight against cancer. Our employees are perceived as passionate, pragmatic and result oriented people dedicated to develop leading edge technologies to protect, enhance and save lives !
If you are stimulated by multicultural challenges and willing to travel, we offer you the opportunity to join a team of more than 35 nationalities working on more than 40 different sites on 3 continents.
IBA offers you a competitive performance based compensation package and a flexible work environment. You have real possibilities to evolve within IBA's worldwide, leading organization and to create your own career path, supported by training programs to acquire new skills and ensure they stay sharp.
As an Equal Opportunity Employer IBA is committed to a diverse workforce.
Quality Manager - MAS PT product installation Application Information
Please apply with your CV and cover letter by the 'apply' button below.
Please use "Qreer.com" as reference in your application.
Quality Manager - MAS PT product installation Summary
| Education Backgrounds: |
Biomedical Science
Electrical Engineering
Mechanical Engineering
|
| Specialties: |
Experimental Physics
Lab Analysis
Pharmaceutics
Quality Engineering
|
| Education Level: |
Postgraduate (Masters)
Doctorate (PH.D)
|
| Experience: |
10 - 15 years
5 - 10 Years
|
| Languages spoken: |
English
|
| Job Location: |
Louvain-la-Neuve, Belgium |
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