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Quality Technology Manager

3 months ago

Northwich Cheshire, Cheshire, 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

As a part of the Quality Department in the Dechra Manufacturing & Supply Division (DM&S), the Quality Technology Manager is responsible for defining and managing the execution of the GxP Computerised System Life-Cycle for the for all GxP software & computerized technology being implemented at the divisional level (i.e., SaaS software packages) ensuring compliance with the applicable regulations including computer system validation and data integrity. Additionally, the role works collaboratively with stakeholders supporting the IT/digital Roadmap and with the wider quality organisation to monitor the effectiveness of the validation and operational quality activities associated with automated systems.



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:

  • Ensures the timely and compliant execution of validation activities for business level GxP SaaS systems performed by the DM&S divisional resources throughout the project live cycle. This includes working collaboratively to establish the necessary resourcing model to deliver the projects on time and maintain the required compliance level through the various continuous release cycles.
  • Work collaboratively with project managers and the project teams to ensure that risks associated with business level GxP SaaS system validation activities are successfully mitigated.
  • Owner of the GxP Computerised System Life-Cycle. Responsible to partner with IT Organization to ensure that products are delivered and maintained in accordance with the compliance requirements.
  • Expert Advisor on matters related to technology QMS, Data Integrity, CSV and other regulatory areas within the computerized systems arena. Conducts gap assessments, and launches initiatives for continuous improvement working with the wider quality team.
  • Develops and implements training programs to maintain compliance and regulatory awareness of topics related to data integrity and computerised systems life-cycle.
  • Provides support for Internal/External Audits in the computerized/software technology space; Leads appropriate quality oversight for GxP technology audits to ensure risk-based review in the connected business processes and highly interfaced system environments.
  • Serves on applicable Program/Project Steering committees for various technology projects.
  • Acts as line manager to both Dechra employees and contractors delivering CSV activities on SaaS products both during the project and operational phases.
  • Owner of the electronic validation management system.


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:

  • Educated to Degree level (or equivalent qualification/experience) in relevant science based or comparable discipline.

  • Pharma/Biotech industry experience with 10+ years' experience in technology- Management/leadership experience.

  • Strong leadership skills with the ability to challenge, influence, and build consensus.

  • A strong track record of establishing and maintaining validation processes/systems which facilitate the delivery of qualification/validation activities to the required quality and regulatory standards.

  • In depth knowledge of relevant regulatory agency guidance in relation to Computer Systems Validation, including FDA, EMA, GAMP, ICH and authorities in other major geographic areas, is essential.

  • Previous experience of participating in regulatory agency inspections and general auditing.

  • Proven ability of accurate and timely completion of tasks.

  • Excellent verbal, written and interpersonal communication in English.

  • Proven ability to be able to manage changing situations with efficiency, calmness, and purpose with the thought to all parts of the business using knowledge of the business and customers to assist.

  • Proven ability as an effective communicator with ability to collaborate and form strong partnerships within teams.

  • Frequent global travel is required with this role.