Quality Specialist - External Network - USA Remote
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 almost 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 Quality Specialist is responsible for supporting the Associate Director – External Networks (CA/MX/US) in:
- Providing Quality oversight of Dechra Contract Manufacturing Organisation (CMO) network.
- The development of systems and processes that ensure that Dechra fulfils its obligations as a Marketing Authorisation Holder in the management of CMO organisations through a partnership approach.
- Establishing and maintaining processes that enable the impact of quality within the CMO network to be tracked, managed and visible enabling effective communication to key stakeholders within DPM&S and the wider Dechra business.
This is a USA remote role.
***No third-party agencies please***
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 confirm the Dechra quality expectations from the CMO network demonstrating maturity, integrity experience and knowledge of subject.
- To support the Associate Director – External Networks (CA/MX/US) 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 external CMO network
- To ensure effective implementation and management of Product Quality Reviews (PQR’s) and Quality Technical Agreements (QTA’s).
- To support CMO 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 CMO network to drive improvements in performance of the CMO network.
- To perform batch disposition where required based on geographic requirements / agreed responsibilities.
- To conduct API and Finished Product disposition processes (where required by geography and regulation) to support Dechra supply chain.
- To lead and / or participate on CMO projects, new technology and technical transfer within CMO 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 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 CMO network
- To support and plan CMO, Supplier, Regulator and Customer audits
- Where assigned as a Veeva Vault Quality Management System (QMS) Sub System Owner (SSO):
- Maintain and where necessary update External Network SOPs in line with VEEVA Vault QMS processes.
- Create / modify training materials that are fit-for-purpose and aligned with the needs of the External Network
- Conduct end-user training for the subsystem to ensure successful adoption
- Oversee the use of the subsystem to ensure it operates smoothly and efficiently within the External 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:
- Degree in a science (Pharmacy, Chemistry, Biochemistry or equivalent) or equivalent experience.
- Minimum of 5 years of relevant Quality Assurance experience.
- 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.
About the Company
As a people first values-based culture, we offer a generous employer 401k match and 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.