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Project Manager QC

Project Management QC GMP Analytical

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for a Project Manager QC.

Keywords
  • M.Sc.
  • Project Manager
  • GMP
  • QC/Analytical Laboratory


The Leiden QC department is looking for a Project Manager to drive the design and deployment of small/medium size capital projects related to analytical equipment and to be a strategic partner with the engineering organisation and the project manager office.
Responsibilities:
  • Lead the conceptual phase of a project in close co-operation with the business stake holders to deliver strategic solutions aligned with the business strategy;
  • Define and lead a multidisciplinary team (internal/ external) to drive the project, in line with the FPX approach;
  • Ensure adherence to policies, procedures, statutory and regulatory requirements and customer specifications;
  • Support the business in clarifying the process flows, developing the business case, the user requirements, defining the CAR strategy and defending the project at various decision levels;
  • Ensure attainment of project schedules, budgets, procedures and revenues by developing and monitoring the budget and approval process;
  • Keep senior management informed on project status by creating, maintaining, and presenting written reports on project status, risks, costs, issues, and performance against established targets on a regular basis;
  • Ensure the documentation of project activities and deliverables;
  • Ensure project change control;
  • Ensure project compliance with EHS&S, GMP and Finance policies and procedures;
  • Develop contacts with business stake holders, colleagues and suppliers;
  • Look for opportunities to improve existing processes;
  • Coach and train selected QC personnel in best Project Management practices and processes.

Profile

The ideal candidate has a Master's degree in Life Sciences with at least 4-5 years of Project Management experience within Biotechnology or Pharmaceutical industry. Additionally, you have the following requirements:
  • Prior experience managing capital projects in Supply Chain, R&D, Distribution Centers or Offices;
  • Manufacturing experience in GMP regulated environments from design through start-up;
  • Experience within QC/analytical laboratory area;
  • Proficient in Microsoft 365 (Outlook, Word, Excel, Projects, Teams and PowerPoint);
  • Understand business needs and is able to translate these to engineering concepts;
  • Technically knowledgeable, can relate to and understand technology-based issues;
  • Ability to lead and motivate remote and virtual teams and stake holders;
  • Good listening and problem-solving skills when managing potential conflicts;
  • Proactive attitude, solutions and results oriented;
  • Excellent communication skills. Ability to develop and maintain collaborative partnerships at all levels within the organisation;
  • Good knowledge of Project Controls in cost and schedule development, financial assessments and managing of budget and schedule;
  • Experience on contracting and negotiation;
  • Maintain compliance with all company policies and procedures;
  • Knowledge of J&J FPX Principles and processes (FPX PL certified) preferred.

Benefits

Salary: >4350
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Project for at least 1 year
32 - 40 hours per week
Hybrid working model - onsite 1-2 days per week

Company profile

Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

The Leiden Quality Control (QC) Leiden department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and vaccines manufacturing site belonging to the Janssen Supply Chain. The Leiden QC department is responsible for raw material, in-process and release testing for products manufactured at the site. Additionally, the Leiden QC department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
Location Leiden
Project Manager QC

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