Director of Quality Assurance

19 hours ago


Oxford, Oxfordshire, United Kingdom Planet Pharma Full time

Job Title: Director of Quality Assurance

Rate: Competitive in line with skills and experience

Type: Permanent

Location: Hybrid


Planet Pharma, a rapidly expanding pharmaceutical organization, is seeking a highly skilled Director of Quality Assurance to join our team on a permanent basis. In this role, you will be responsible for developing and leading the Quality Assurance function for the business.


Key Responsibilities:

  • Develop and implement a quality strategy that aligns with the company's goals and objectives.
  • Oversee the development, implementation, and maintenance of the company's Quality Management System (QMS) to ensure compliance with applicable GMP, GDP, GLP, GCP, and GPvP guidelines.
  • Manage the implementation and operation of electronic QMS solutions as required.
  • Establish a risk-based approach for the supervision and monitoring of GxP-related activities, including the development of a governance framework with relevant metrics and measurements.
  • Lead the Quality Management Review process.
  • Implement and oversee a vendor management program for the qualification and monitoring of GxP vendors.
  • Manage the GxP audit program and conduct audits as needed.


Qualifications:

  • Significant experience in the development, manufacturing, and quality control of sterile pharmaceuticals.
  • Experience engaging with regulatory agencies, including managing inspections, attending scientific meetings, and addressing review questions.
  • Demonstrated expertise in designing, implementing, and managing Quality Management Systems.
  • Experience leading a team of QA professionals to deliver high-quality outcomes for the organization.


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