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Head of Pharmaceutical Development
2 months ago
We are seeking a highly experienced and skilled professional to join our team as a Director of Quality and Compliance. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our pharmaceutical development activities.
Main Responsibilities- Quality Management Systems: Design and implement quality management systems for CMC development activities, including the release of products for GLP and GCP studies.
- Product Characterization: Provide quality expertise in the creation of product characterization, product specifications, method validation, stability, and comparability assessments for technology transfers for veterinary medicinal products.
- Collaboration and Oversight: Ensure quality expertise is provided in the various phases of the development process, including collaboration with Contract Development and Manufacturing Organizations (CDMOs).
- Process Validation: Ensure robust processes are in place for the review and release of products for GLP and GCP studies.
- Supplier Qualification: Manage supplier qualification and requalification activities for CDMOs.
- Data Integrity: Establish systems to assure compliance with data integrity and traceability for regulatory submissions.
- Process Improvement: Identify opportunities for improvement to quality processes and systems and drive these to completion.
- Leadership and Coaching: Lead the CMC Quality team and wider Dechra Quality community to develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality risks.
- Pharmaceutical Industry Experience: Extensive experience in the pharmaceutical industry, with hands-on experience in development and quality in a GxP environment.
- Quality Strategies: Proven track record of implementing phase-appropriate quality strategies.
- CDMO Oversight: Direct experience providing quality oversight of CDMOs.
- Regulatory Knowledge: Excellent working knowledge of FDA and EU GMPs, including interpretation of requirements and guidance for the development, manufacture, control, and distribution of commercial products.
- Drug Development Process: Deep knowledge and understanding of the drug development process and global regulatory requirements and regulations related to GXP.
- Manufacturing Experience: Strong understanding of small molecule manufacturing, with direct experience in solid oral dosage forms. Biotechnology experience is desired.
- Risk Assessment: Proficient in risk assessment and mitigation tools and processes.
- Education: Bachelor's, Master's Degree, or PhD in a relevant field, such as chemistry, pharmacy, pharmaceutical science, biology, life science, or comparable discipline.
