Janssen Vaccines & Prevention B.V., previously Crucell, is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. They are dedicated to bringing life-saving innovation to global health.
Herakles Pharma Staffing is currently looking for a Quality Manager GMP. You are working on the Product Quality Management (PQM) team at Janssen Vaccines. You will support the team in the Covid-19 vaccine project. The position is linked to the Janssen Vaccines & Prevention organization, which is based in Leiden, the Netherlands.
Main responsibilities for the function as a Quality Manager GMP:
You will be working with the PQM team to ensure that product quality aspects of the Covid-19 vaccines, including the original variant and new variants, are tracked and consistently met.
You will ensure that information and data on the Covid-19 vaccine project are structured for easy access and interpretation;
In (sub)projects for the vaccine, you will represent PQM on the project team;
Also, you will be working hands-on at operational activities such as complaints, deviations, change controls, and regulatory reviews;
In all activities, you bring creative solutions to define quality solutions with flexibility for business needs, thus providing the best total value to the company.
Requirements for the role as a Quality Manager GMP:
A minimum of a Bachelor’s degree (or University equivalent) in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or Life Sciences. A Master’s or advanced degree is preferred;
You have at least 5 years experience in cGMP, quality systems and processes, e.g., change control, deviation handling, CAPA, risk management, complaints handling, (regulatory) inspections, and manufacturing control strategies. This enables you to, after having received the appropriate training, also take up tasks independently;
Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary; balancing work and personal time is required;
You are an EU Citizen, fulltime available and you live within commuting distance from Leiden.
This is a fulltime contracting position for initially one year through Herakles Pharma Staffing either as a freelancer or as an employee. The maximum hourly rate for a freelancer is € 87,- (all-in, ex VAT). The maximum annual year salary for an employee is € 98.000,- on fulltime employment and is depending on relevant work experience.
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