Divisional QMS Manager

3 months ago

Northwich, United Kingdom Dechra Full time
Summary

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.

Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of over 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.

The Opportunity

The purpose of this role is to develop, implement, maintain, and continuously improve Dechra Group and DM&S Divisional Quality Management System processes and procedures that will create an acceptable baseline level of quality and GMDP control across different sites and business units, drive quality improvement, and increase operational efficiency.

These processes will be based on Quality Risk Management (QRM) principles in accordance with ICHQ9 (R1) and introduce the use of a Dechra Group Quality Manual, Quality Risk Register (QRR) and guidance and templates for Standard Management Reviews (Quality Councils), and Quality Improvement Plans (QIP).

Main Responsibilities

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

  • Create, implement, and maintain procedures and guidelines related to Dechra's QMS at a divisional level (specifically Change Control, Deviation, CAPA, and Continuous Improvement), with the input from the Divisional Quality Team and wider business.

  • Ensure Quality Risk Management is implemented across GMDP areas of the business via the Group Quality Documents framework in accordance with ICHQ9(R1), including the creation of a standard risk priority assessment tool and a Quality Risk Register.

  • Be responsible as the Group owner of the consolidated Quality Risk Register (QRR) process for GMDP operations. This responsibility includes:

  • Ensuring the QRR process is embedded across quality at all levels.

  • Holding proactive QRM review discussions with the quality organisations to ensure emerging risks are being actively identified and managed.

  • Managing the QRR / QRM escalation process ensuring that the highest risks are visible to stakeholders and management at the required cadence for business reporting.

  • Act as the Quality Lead for changes being implemented at the divisional level as required.

  • Work with the owners of core divisional applications (e.g., Oracle, Veeva, etc.) to ensure that quality business processes remain aligned with the various applications both from an IT system and business process perspective.

  • Work with Internal, External and GDP Operations Leads to ensure that the Dechra Quality Management review process and cascade is driving quality improvement across the organisation.

  • Own the full life-cycle of the Dechra Group Quality Manual, including the development of templates for Site Master Files.

  • Support the development and implementation of a Dechra Group Quality Improvement Plan to monitor and address complex compliance issues.

  • Support GMP and GDP training improvement at all levels of the business as required include non-pharma sources.

  • Support wider quality teams where required.

  • Hold line management responsibilities as required as the organisation grows.

Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are:

  • Significant experience in the pharmaceutical industry, preferably the
    veterinary pharmaceutical industry.
  • In depth knowledge of relevant regulatory authority guidelines,
    including the UK/EY/US GMP's and GDP's and ICH 10.
    * A sound understanding of the principles of Quality Risk
    Management, including ICH Q9.
  • A strong track record of establishing/improving processes
    and systems which facilitate the delivery of activities to the required
    quality and regulatory standards.
  • Strong leadership skills and the ability to challenge, influence and build
    consensus.
  • A proven ability to be able to manage changing situations with efficiency,
    calmness, and purpose.
  • Excellent verbal, written and interpersonal communication in
    English
  • Effective technical and non-technical communicator.
  • Degree in a science or engineering based
    subject or equivalent experience.
  • Occasional global travel may be required with this role.

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