Sr Compliance Supervisor

iindustrial experience, GMP, EHS, GAMP 5, Annex 1

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Vaccines & Prevention we are searching for a Sr Compliance Supervisor.

Keywords
- 10 years industrial experience;
- GMP and EHS knowledge;
- pharmaceutical regulations a GAMP 5 and Annex 1.

As Sr Compliance Supervisor, you will lead a team of highly qualified engineers/technicians within the EVM department. You will get the best out of your people by taking diversity, inclusion and equity aspects into account and you are responsible to deliver high-quality within the complexity and dynamics of a research and development organisation. As MT member, you lead the department to develop to the next level and take ownership for the broader organisation.
You will work closely with the other EVM team leads and internal partners to maintain/improve the department’s high GMP and EHS standards fulfilling the needs of a safe, high quality and continuously improving R&D organisation.
You will be responsible for:
  • People management, ensuring that there is a stable team with a positive constructive atmosphere. You motivate, coach, and support your employees to get the best out of your team;
  • Perform people management tasks e.g., holds the "5 conversations, recruitment and selection, absenteeism guidance, coaching, propagating the CREDO values;
  • Setting priorities and aligning them with the departments involved, constantly assessing, and improving the efficiency of the quality and safety processes and the team, so that the technical assets and the resources are optimally utilised;
  • Defining team objectives, translating them into activities and responsibility to achieve the overall results of those activities;
  • Ensuring the Life cycle management of technical assets is performed in accordance with pharmaceutical regulations, e.g.: GAMP 5, Annex 1;
  • Ensuring the implementation/maintenance/continuous improvement of all safety aspects of the Johnson & Johnson EHS program within the field of the Engineering and Maintenance processes;
  • Ensuring ownership of company quality standards and procedures;
  • Ensuring the implementation/maintenance of systems capable of visualising departmental performance;
  • Ensure departmental readiness for internal/external audits on quality and safety;
  • Improving the department by using PE tools, Project management tools, and departmental goal setting;
  • Ensuring sufficient training (regulatory requirements, process excellence, etc.) and occupation of the team members.

Profile

The ideal candidate has a B.Sc. in engineering, biotechnology or automation with at least 10 years of experience in biotechnology/pharmaceutical/process industry environment with people management experience. We are looking for someone with excellent people management skills: supportive leadership, change management skills, motivating and coaching, developing the individual and the team to a higher level. Furthermore, you have the following knowledge/skills:
  • Proven organisational, managerial capacities and demonstrated flexibility to respond to changes in the external and internal environments;
  • Knowledge of pharmaceutical manufacturing, current Good Manufacturing Practices (cGMP) and safety regulations;
  • Validation and qualification aspects of pharmaceutical and/or bio processing equipment, utilities and facilities;
  • Strong influencing skills with ability to see issues from multiple viewpoints;
  • Good command of English in word and writing;
  • Experience with Lean methodology is preferred.

Benefits

Project for 1 year with intention to hire permanently
Salary:
Days of leave: 25
See here our other employment terms for this vacancy

Company profile

Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.

Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A2300078)
Location Leiden
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Sr Compliance Supervisor

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