Director Quality CMC Development

Company: Cpl Healthcare
Location: Boston
Posted on: November 17, 2024

Job Description:

Director of Quality CMC Development - East Coast based remoteThis role offers the flexibility to work remotely from locations within the U.S/Canada, with a preference for Eastern Time Zone working hours to collaborate with EU teams.Travelis required.Position Overview:Cpl Life Sciences is looking for a Director of Quality CMC Development (Product Development), you will lead and oversee the formulation and process development ofanimal health productsthroughout the entire Chemistry and Manufacturing Controls (CMC) lifecycle. Your primary responsibility will be toensure that new product manufacturing and control processes are robust, reliable, and compliant from the early stages of development through to process validation and technology transfer activities.Key Responsibilities:

• Develop and implementquality management systems that ensure compliance with cGMP requirements, tailored to each phase of the product development lifecycle.
• Collaborate closely with Product Development, Manufacturing Sciences & Technology, Regulatory Affairs, Site Quality (QA and QC), and both Internal and External Manufacturing teams to ensure quality integration.
• Lead and mentor the CMC Quality team and quality professionals across global operations, promoting a culture of excellence.
• Design and oversee the implementation of quality systems specifically for CMC development activities, including the release of products for GLP and GCP studies.
• Provide quality expertise tosupport global standards in the development of productcharacterization, specifications, method validation, stability, and comparability assessments, with a focus on veterinary medicinal products during technology transfers.
• Ensurequality oversight throughout all phases of development, including partnerships with CDMOs.
• Establish robust processes for the review and release of products intended for GLP and GCP studies, ensuring data integrity and compliance.
• Oversee GMP activities conducted by Product Development teams, CDMOs, and contract laboratories, including the review and approval of critical documentation such as protocols, reports, and master batch records.
• Manage supplier qualification and requalification activities for CDMOs, ensuring consistent quality standards.
• Identify and drive improvements in quality processes and systems to enhance overall product quality and compliance.
• Lead the broader Quality community in developing, approving, and maintaining critical quality standards that minimize product quality risks and support lifecycle product quality monitoring.
• Support Quality team members in achieving product and process development requirements.Ideal Candidate Profile:We are seeking candidates who bring a strong background in pharmaceutical product development and quality within a GxP environment.The ideal candidate will have:
  • Extensive experience inpharmaceutical product development and quality assurance, with a focus on the veterinary sector.
  • A proven track record ofimplementing phase-appropriate quality strategies that balance innovation with regulatory compliance.
  • Direct experience in quality oversight of CDMOs and managing relationships with external partners.
  • Deep knowledge of Regulatory Affairs, FDA, and EU GMPs, particularly in relation to the development, manufacturing, and distribution of veterinary medicinal products.
  • Expertise in small molecule manufacturing, especially in solid oral dosage forms, with additional experience in biotechnology being a plus.
  • Proficiency in risk assessment and mitigation, with a strong understanding of global regulatory requirements.Preferred Qualifications:
    • A Bachelor's, Master's, or PhD in a relevant field such as chemistry, pharmacy, pharmaceutical science, biology, life science, or a related discipline.Needed Areas of Expertise:
      • CMC
      • Research and Development
      • Quality Management
      • Product Development
      • Animal Health OR extensive Pharmaceutical/Biotechnology experience
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Keywords: Cpl Healthcare, Portland , Director Quality CMC Development, Executive , Boston, Maine