GDP Quality Manager

Job Introduction

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

Dechra is 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

Responsible for the supporting the Head of GDP Quality Operations in:

Providing Quality oversight of Dechra distribution network in the US.
The development of systems and processes that ensure that Dechra fulfils its obligations as a distributor through a partnership approach.
Establishing and maintaining processes that enable the impact of quality within the distribution network to be tracked, managed and visible enabling effective communication to key stakeholders within DM&S and the wider Dechra business.

Role Responsibility

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

To support the Head of GDP Quality Operations in the definition, development, implementation and refinement of appropriate Key Performance Indicators (KPI’s) for senior management in order to monitor the effectiveness of the GDP network in the US.
To ensure effective implementation and management of GDP related contractors and Quality Technical Agreements (QTA’s).
To support GDP network management in recalls, complaints, change controls, deviations, sanctions as per the contractual and service level agreements.
To support the development and maintenance of risk assessment process (in line with ICH Q9 or equivalent Regulatory Guidance) and to monitor KPI’s across the GDP network to drive improvements in performance of the GDP network.
To ensure batch disposition where required based on geographic requirements / agreed responsibilities.
To lead and / or participate on GDP related projects, new technology and technical transfer within GDP network and associated validation, problem shooting including liaising with technical, commercial and supply chain stakeholders.
To ensure logistics and supply chain is quality compliant and supports Dechra’s strategic aims. To provide quality guidance in order to ensure Good Distribution Practice (GDP) across the supply chain and to ensure quality adherence across the supply chain in its entirety.
Contribute to manufacturing, supply chain and technical services in daily work, projects and programmes, with the focus being to ensure quality is embedded at all stages of products from New Product Introduction (NPI), transfer, manufacture and distribution.
To ensure effective communication with to drive the quality agenda, to liaise and co-operate with all other Departments to ensure good communication and timely identification and resolution of issues.
To report and create action plans, as necessary on changes in standards (internally and externally initiated) and on performance against standards.
To liaise with suppliers with respect to quality incidents in supporting existing business and to provide quality oversight of new product introductions and technical transfers within the GDP network.
To support and plan GDP Supplier, Customer, Regulator and 3PL audits related to the GDP network.

The 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 excited to hear from those who have/are:

Bachelor degree (Pharmacy, Chemistry, Biochemistry or equivalent)
Demonstrated pharmaceutical quality experience, including working within quality systems such as audit programmes, change control, complaint handling and investigations.
A thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
Experience of supporting regulatory inspections, client audits and self-inspections
Technical knowledge to support quality and validation decision making
Relevant Quality Assurance experience
Proven quality specialist capabilities in a quality role associated with GDP.
Detail oriented
Diplomatic with good listening skills.
Mature, confident and effective communicator.
Pro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracy.
Proven ability as an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders /customers that result in "win-win" outcomes to achieve business goals and objectives.
Fully IT literate: Microsoft Outlook, Word, Excel.
Highly self-motivated with strong inter-personal skills.
Ability to work with cross-functional teams on new process projects and process improvements.
Ability to prioritise work and handle multiple deadlines.
Travel will be required for this role

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.