Job Description
Job Title: Head of Quality Assurance
Rate: Competitive in line with skills / experience
Type: Permanent
Location: Hybrid
My client, a rapidly expanding organisation currently have an urgent requirement for a talented Head of Quality Assurance to join on a permanent basis. In this role you will be responsible for developing and leading the QA function for the business.
Key Responsibilities:
* Lead the quality planning process to create a quality strategy that aligns with the company's goals and objectives.
* Develop, implement, and oversee 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 (such as FDA, EMA, or national EU 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.
Interested? Apply now for immediate consideration or contact Michael Owusu-Ansah on +44 203 928 6631 – mowusu-ansah@planet-pharma.co.uk
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