Brabant Wallon – contracting

Our partner is looking for a Global Quality Lead Solutions Partner to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.

• Product Change Control Committee preparation and change controls follow-up, quality review for change proposals related to the product life cycle management.
• Maintenance and lifecycle management of QA product flows
• Audits and Inspection readiness
• Product metrics
• Review of Annual Stability Plan
• SOPs and other control documents writing, review and approval as needed
• Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
• Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
• Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
• Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed
• Product Impact Assessment as required to support deviations and investigations.
• Interface with Medical Information Team and prepare answers to their requests and questions related to the product in scope.

Additionally, the Global Quality Lead Support will represent the Global Quality Lead team when assigned to projects and initiatives.It can also include a support role for:

• Product Quality Complaint Committee preparation and complaints oversight
• Product recall and product escalation meeting preparation
• Annual report (i.e., reporting of change controls to Health authorities…)
• Yearly Biological Product Report
• Reviewer and approver of Global Specification for the accountable products
• Reviewer and approver of Master BoM (Bill of Materials)
• Act as the backup of GQL as needed

• Minimum Level of Education Required - Bachelor's Degree
• Minimum of 5-10 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience with biotechnological and/or aseptic processes, GMP in Quality, Manufacturing, or Quality Control would be an asset.
• Fluent and confident use of English language verbally and in reading & writing.
• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
• Must be able to work autonomously for the assigned activities with limited supervision.
• Must be skilled and experienced in operating across cultures and in a multi -cultural environment.
• Must be able to independently analyze data and information to draw conclusions and make effective decisions.
• Must have the ability and agility to adapt to different type of products, tasks and Quality Leads in a collaborative mindset.
• Must be able to identify and suggest harmonization and synergies opportunities to improve ways of working across global products.
• Must be able to deliver presentations or reports adapted to the audience.
• Must possess good interpersonal, verbal, and written communication skills.
• Must have ability to identify risks and propose corrective actions within areas of expertise.
• Experience in GMP audits and inspections would be an advantage.
• Project management skills would be an asset.
• Experience in Data Integrity assessment would be an asset.
• Understanding of CMC Regulatory requirements is a must

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

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