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- Designs and oversees the implementation quality management systems for CMC development activities including the release of product for GLP and GCP studies.
- Provides quality expertise in accordance with the global quality requirements in the creation of product characterisation, product specifications, method validation, stability and comparability assessments for technology transfers for veterinary medicinal products.
- Ensures quality expertise is provided in the various phases of the development process, including in the collaboration with C(D)MOs.
- Ensures that there are robust processes in place for the review and release product for GLP and GCP studies.
- Ensures appropriate quality oversight of GMP activities performed by the Product Development teams at Dechra or CDMOs and contract laboratories. This may include review and approval of protocols, reports, methods, master batch records, etc.
- Manages supplier qualification and requalification activities for CDMOs.
- Establishes systems to assure compliance with data integrity and traceability for regulatory submissions.
- Identifies opportunities for improvement to quality processes and systems and drives these to completion.
- Leads the CMC Quality team and wider Dechra Quality community to develop, approve, monitor and maintain critical quality standards to proactively minimise product quality risks including application of controls supporting risk-based continued process verification and monitoring of lifecycle product quality.
- Supports the wider Dechra Quality team members regarding the requirements for product and process development.
- Extensive Pharmaceutical Industry with hands on experience in development/quality in a GxP environment.
- Proven track record of implementing phase appropriate quality strategies
- Direct experience proving quality oversight of CDMOs
- Excellent working knowledge of FDA and EU GMPs, especially in the interpretation of requirements and guidance for the development, manufacture, control, and distribution of commercial product
- Deep knowledge and understanding of drug development process and the Global Regulatory Requirements and regulations related to GXP.
- Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms. Biotechnology experience is desired.
- Proficient in risk assessment and mitigation tools and processes
- Excellent problem solving and decision-making skills.
- Strong interpersonal skills, collaborative and team building skills.
- Broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals with measurable impact and outcomes.
- Ability to speak, present data, and defend approaches in front of audiences.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Strong written and oral communication skills, able to translate complex concepts across all levels of the organization.
- Able to manage multiple priorities with priorities with aggressive timelines.
- High impact and influencing skills.
- Bachelor's, Master's Degree, or PhD in a relevant field - chemistry, pharmacy, pharmaceutical science, biology, life science, or comparable discipline.
- Extensive travel is essential for this role
Director Quality CMC Development - Cheshire, United Kingdom - Dechra
Description
Summary Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.Here at Dechra, our values are embedded within our culture and thrive within our family of more than 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.
This role can be performed remotely in US, UK and any European Dechra entity.
The Opportunity
Dechra is an international specialist veterinary pharmaceutical products business. Our expertise is in the development, manufacture, sales and marketing of high quality products exclusively for veterinarians worldwide.
The Director Quality CMC Development provides the quality direction and oversight for the formulation and process development activities for Dechra's products across the CMC (chemistry and manufacturing controls), from early development studies to process validation, including support for technology transfer activities. To ensure that new product manufacturing and control processes are robust and reliable, it is critical that the appropriate quality oversight is provided at each phase of development. This is accomplished through: 1) the establishment of quality systems designed to deliver cGMP compliance in a phase-appropriate fashion; 2) partnership with Product Development, Manufacturing Sciences & Technology, Regulatory Affairs, Site Quality (QA and QC), and Internal and External Manufacturing; and, 3) leadership and coaching of the CMC Quality team along with those quality professionals across the Dechra group.
The Director Quality CMC Development will be a member of the Quality Assurance team and report to Group Quality Director. The Director Quality CMC Development will have a dotted line to Dechra's Product Development department (PDRA) to ensure alignment with the PDRA goals and objectives.
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:
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:
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