Senior Project Manager

Senior Project Manager - Leiden

Project/Department Description and responsibilities

The project member documentation will work in the Leiden Vaccine Launch Facility (VLF) organization and will report to the Sr. Quality Engineer.

The Vaccine Launch Facility department consists of 30 people, the interdepartmental project team has 2 members (Sponsors and stakeholders not inclusive)

There is need for a contractor to improve the structure of the site standard operating procedures and reduce redundancy.

The contractor should be experienced in working with document management systems .eg Docspace.

Primary Tasks and responsibilities

Work with stakeholders across the various departments to get the Documents at a GMP Quality level

Depending on the contractors capabilities Primary Tasks and responsibilities will be further defined.

Technical profile requirements

The contractor should have technical writing skills to write the proper documentation according to regulations guidelines (FDA part 11, GxP)

The contractor should have a track record with document development, improvement and implementation.

The contractor should have a number of years relevant working experience within the (bio) pharmaceutical industry.

Deliver documents within requested timeframe and budget

The contractor should preferably have knowledge of and have experience with using various improvement techniques such as Lean six sigma, Kaizen and 5S.

The contractor should have affinity with GMP and biotechnology.

Experienced in process and documentation improvements is essential (plan, schedule, issue tracking/remediation, risk analysis, etc.)

Non-Technical profile requirements

Accepts personal responsibility for client satisfaction

Strong tracking, coordination and project planning skills

Ability to identify and implement process and/or application improvements

Strong analytical and problem-solving skills

Must be able to work on multiple simultaneous tasks with limited supervision

Quick learner, motivated self-starter

Excellent customer service, interpersonal, communication and team collaboration skills

Able to follow change management procedures and internal guidelines

Bachelor/Master Degree in Engineering, Life Sciences or equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred

Deliverables

Updated general process documentation eg SOP's WI's, in line with GMP and internal requirements.

Approved and effective GMP documentation package.

Overview of effective documentation and visualization of the links between the individual documents.

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.