Director Quality CMC Development
4 months ago
- 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
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