Quality Assurance Manager / Deputy of Chief Pharmaceutical Officer - France
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), the Netherlands (Leiden), Germany (Munich), France (Romainville / Paris), Switzerland (Basel), UK (London), Italy (Milan), Spain (Madrid) and in US (Boston).
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you.
We are looking for a Quality Assurance Manager / Deputy of Chief Pharmaceutical Officer for France
Scope of the job
In accordance with the company's strategy, ethical rules and procedures in force at global and local level, the Quality Assurance Manager has the permanent missions of:
- Manage the Exploitant Quality System in accordance with the Chief Pharmaceutical Officer (CPO) defined strategy,
- Participate in improvement of the Quality System and ensure Exploitant's compliance,
- Contribute to training actions to leverage the employee’s knowledge of regulatory requirements,
- Prepare inspections and conduct or assist quality audits,
- Manage the pharmaceutical suppliers.
As a Quality Assurance Manager (QAM)
- Take on the role of QAM in accordance with the Exploitant status regulations, with the Charter for the promotion and the Global Policies defined by the Galapagos NV. Ensure that the quality system complies with these guidelines in relation to the other Departments. Be responsible in relationship with the CPO for the operational relationship with the marketing authorization holder and all pharmaceutical suppliers in terms of ensuring that regulatory compliance is upheld and that the contracts and quality agreements for these are updated regularly;
- Develop, update and pursue continuous improvement of the Quality System;
- Collect, monitor and update pharmaceutical documentation;
- Monitoring of pharmaceutical suppliers;
- Ensure or participate in inspections, internal audits and audits Charter of the promotion. Coordinate and participate in the mobilization of all the actors concerned with a view to the preparation of these inspections and audits. Ensure their proper implementation, the link with Galapagos NV and the follow-up of these inspections and audits.
- Participate in the development of corrective actions and their documentation;
- Contribute to the promotion of Quality within the Galapagos Exploitant site through awareness-raising and / or training actions. Set up, implement and ensure follow-up of mandatory regulatory trainings, in particular quality, pharmaceutical and Charter for the Promotion-related training, for all employees of Galapagos Exploitant. Participates in the development of the Exploitant provisional training plan, its monitoring and its summary.
As a Chief Pharmaceutical Officer (when replacing the Chief Pharmaceutical officer)
- Personal duties of the Chief Pharmaceutical Officer of the Exploitant pharmaceutical establishment Galapagos Exploitant Site during replacement periods (art L. 5124-4 of the PHC) and is responsible for all pharmaceutical operations (sections 2.2 and 2.3 of GMP) it organizes and supervises (art R. 5124-36 of the Public Health Code).
Who are you?
- Pharmacist, qualified for a registration in section B. Training in Pharmacovigilance. Preferably with a healthcare law degree.
- At least 5 years’ experience in an Exploitant pharmaceutical establishment as Chief Pharmaceutical Officer or Deputy of Chief Pharmaceutical Officer.
- Good knowledge of French Legislation regarding the activities of Exploitant.
- Rigor, organization, anticipation.
- Strong analysis and synthesis.
- Skilled at decision-making with a transversal vision.
- Genuine teamwork mentality, strong clear communication and negotiation skills.
- Fluent French and English (professional level).
What’s in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!