Senior Manager QC & Analytical - Brussels M/F
Well known and established business based south of Brussels
Quality Control & Analytical Development
À propos de notre client
Our client is a global player in the manufacture and development of Bio Pharmaceutical products with offices based south of Brussels. This company can truly promise you a career and development within the business.
Description du poste
The role Senior Manager QC & Analytical M/F of acts as an internal Project Manager who is ultimately responsible for managing all analytical activities on several products as well as on life cycle projects bringing the analytical and stability expertise to multi-disciplinary teams and Governance bodies.
You will essentially act as a consultant to the business with the goal of harmonising best practice and finding solutions to QC and Analytical challenges around the product portfolio.
- Leading, developing and coach a team accountable for the analytical lifecycle product management.
- Promoting QC analytical product expertise within the QC product/stability group and ensuring practices harmonise across the different products
- Responsible for the analytical and stability sections of the product quality review and the coordination of the implementation of identified improvements (CAPA's).
- Managing QC sections of regulatory files, variations and Question and Answer reports.
- Responsible for the analytical content of each product Regulatory file and acting as key player during Regulatory inspection and meetings.
- Accountable for the QC Change control management identified within Technical Team.
- Accountable for the coordination of critical product deviations, in cooperation with the key members of the multi-disciplinary Technical teams, to guarantee the continuity of supply and are in accordance with the current regulations.
- Identifying risks on technical feasibility and supply, timing and resources constraints and seeking a remediation plan for identified risks.
- Coordinating the alignment of QC labs deliverables link to testing of lifecycle product improvement projects in line with Global supply chain objectives.
This role is crying out for a QC professional who has the depth of experience in Quality Control but is looking for their next step in the Bio Pharmaceuticals industry.
The role is based at the state of the art facility in the South side of Brussels and offers one of the best work environments in the whole of Belgium. To be considered for the role of Senior Manager QC & Analytical M/F based near Brussels.
- Master or PhD degree in chemistry, biology, bioengineering or pharmacy 10-15 years in the Pharmaceutical industry with experience in Quality Control, analytical development, regulatory, R&D and/or lifecycle management in the fields of biologics, vaccines and/or bio Pharmaceuticals
- Demonstrated leadership and transversal people management skills in either man management of teams of Project and Program management. Knowledge of Vaccine testing and manufacturing environment. Excellent understanding of the framework within which a pharmaceutical product has to be developed and maintained in compliance with GMP's and regulatory requirements.
- Ability to evaluate product compliance and quality issues and make sound recommendations regarding problem resolution.
- Ability to communicate complex information both orally and in writing.
- Ability to listen effectively.
- French speaker with the ability to communicate at a business level in English
Conditions et Avantages
A six figure salary and package which reflects the seniority of the role.