Head of Investigational Medicinal Product Quality
il y a 1 semaine
Site Name:
Belgium-Wavre, Italy - Rosia
Posted Date:
Jan
As Head of Investigational Medicinal Product Quality (IMP) Control Strategy Operations, you will develop and ensure the execution of quality operations which ensures Investigational Medicinal Product (IMP) used in GSK are produced in compliance with applicable regulations and GSK quality expectations are released promptly to meet clinical study and development timelines.
In TRD M&CS and ARD, we have the chance to work with all vaccines technologies (CHO, Virus, mRNA, adjuvants, polysaccharide, eColi...) from the cell bank to the final product, providing a rich and stimulating environment.
Key Responsibilities will be:
- You will collaborate with Operative Staff, Quality Staff, and Senior Leadership Team to grow capability in understanding regulatory changes
- You will develop strategic direction and ensures execution of continuous improvement through idea development, plan creation, implementation, and championing project management methodology for projects of high complexity and risk
- You are accountable for the Quality release of incoming materials and overseeing the QC release of clinical material from Phase I to Phase III
- You are accountable for Quality oversight of the TRD M&CS and ARD GMP activities including:
- Incoming material qualification, In process & Manufacturing controls, Release testing, Qualification Status, Analytical Validations, Stability, Shelf-life/Expiry dates and Sample management
- Embedding with business Quality governance and support to their Management Monitoring and continuous improvement initiatives
- You will be cocreating with business improving endtoend & codevelopment perspective, increasing speed to market, leaning processes in order to foster innovation, ease Control strategy execution and strengthen data & documentation generation
- You are accountable for supporting audits, both internal and external
- You are accountable for Deviation, CAPA, Change control and Quality Systems in general oversight
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- You have successfully completed master's degree in life sciences or related fields
- Extensive years of experience in pharmaceutical industry, preferably in API production and/or Quality organization (incl. Quality control).
- Multiple years of work experience in quality assurance, quality oversight or relevant experience, ideally in a biotech or pharmaceutical company
- Strong Experience in contract manufacturing or in dealing with contract manufacturers
- Profound knowledge of EU GMP and FDA regulations for clinical manufacturing
- Experience in the manufacturing of investigational medicinal products for clinical studies of phase I to III
- Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
- Proven track record of managing people and complex programs
- Experience with Clinical Good Manufacturing Practices, FDA and other regulatory requirement
- Strong knowledge of regulations and technical, to influence the operations (TRD ARD & M&CS) and their processes.
- Demonstrable negotiation skills required to negotiate with auditors, both internal and external.
- Experience in managing the navigation of decisions and/or their execution through multiple parties in complex, matrix organizations.
- Strong written and oral communication skills in English
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Master's degree in Bioengineering together with substantial industry experience in Pharma/ Biotech R&D
- A strong sense of initiative, urgency, pragmatism, judgment an ability to make things happen.
- Provide insight into related crossfunctional R&D/Research projects.
- Proven Influencer will establish and enhance relationships with key senior management in supported customer groups.
- Critical thinking and leadership skills will allow to Guide teams on drawing out and prioritizing strategic questions and choices.
Why GSK?:
GSK's portfolio spans three product areas: vaccines, specialty and general medicines and our focus is to deliver better and faster for patients globally.
Our unrivalled vaccine portfolio targets infectious diseases at every stage of life, helping to reduce the burden of disease for hundreds of millions of people.
GSK has exceptional capabilities in vaccine science and technologies, including adjuvant/protein and mRNA.In specialty medicines, we are at the forefront of HIV prevention and treatment, and we are building our presence in key therapeutic areas such as oncology and immuno-inflammation.
General medicines include our inhaled medicines for asthma and COPD, antibiotics and medicines for skin diseases.By 2031, we aim to deliver more than £33 billion in annual sales - a step-change in performance and growth which will si
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