Regulatory, QMS

2 weeks ago

St Neots, United Kingdom Ennov Full time

Reporting to the Group Quality Manager (who is also our Group Data Protection Officer), the Regulatory & Quality Engineer ensures that the company's quality policy is implemented and respected, and plays a pivotal role in matters relating to the Quality Management System.


Operating in an environment with high regulatory requirements, they contribute to the efficiency of the company's processes while ensuring compliance with applicable standards throughout the company’s subsidiaries.


Work Location:

  • UK (St Neots, Cambs.) or FRANCE (Paris)
  • Hybrid or Home-based possible.


Key Responsibilities


Audit Co-ordination :

  • Lead and co-ordinate customer audits, including scheduling, preparation, execution, and follow-up activities.
  • Conduct regular internal audits to identify areas for improvement and ensure adherence to quality standards.
  • Manage the process of responding to customer questionnaires and feedback, ensuring timely and accurate responses.
  • Contribute to the supplier qualification processes, including conducting supplier audits and assessments to evaluate supplier capabilities.


Maintenance of the QMS:

  • Contribute to the creation, maintenance, and organisation of quality-related documentation, including SOPs, work instructions, quality manuals, records and training material.
  • Establish key performance indicators (KPIs) and metrics to measure and monitor quality performance throughout the organisation.
  • Collaborate with cross-functional teams to resolve quality-related issues and implement corrective/preventive actions in a timely manner.


Active Contribution to Quality Culture and Awareness

  • Train and educate staff on quality procedures and best practices.
  • Champion a culture of quality throughout the organisation, promoting awareness, accountability, and a relentless focus on customer satisfaction.


Regulatory Monitoring / Compliance

  • Stay informed about relevant regulations and standards in the industry, providing guidance for the business to ensure compliance with all applicable requirements.
  • Contribute to continuous improvement initiatives.



Required Qualifications, Skills & Experience

  • Degree in a relevant area of studies.
  • 2 - 3 years’ experience in the role out of Quality policies.
  • Knowledge of Quality Management Systems (QMS).
  • Proven Auditing Skills.
  • Continuous Improvement Mindset.
  • Excellent interpersonal, verbal, and written communication skills.
  • Experience of working at the headquarters of an international company.
  • Fluent in English (ideally with business French).


Nice to Haves

  • Data Protection Officer certification.
  • Knowledge of regulatory requirements specific to the pharmaceutical industry (e.g., FDA 21 CFR Part 11).
  • Experience with Agile or Scrum Methodologies.
  • Proficiency in Electronic Document Management Systems (EDMS) and other quality management software.


Salary according to skills and experience.

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