Head of Quality
UK based, hybrid/remote working options
Negotiable salary
Cpl Life Sciences have partnered with a clinical-stage radiopharmaceutical company focused on advancing next-generation targeted radiotherapies for cancer treatment to recruit for a Head of Quality.
Purpose:
- Develop and lead the Quality Assurance (QA) function for all development activities to ensure regulatory compliance, product safety, data integrity and patient focus.
- Work cross functionality to foster a quality culture and promote continuous improvement across the organisation.
Duties:
- Lead the quality planning process to define the quality strategy in alignment with company goals and objectives.
- Implement and maintain a quality risk register.
- Design implement and maintain the client Quality Management System (QMS) to ensure compliance with relevant GMP, GDP, GLP, GCP and GPvP guidelines.
- Implement, manage / own electronic QMS solutions as required.
- Implement a risk-based system to ensure oversight and monitoring of GxP related activities (via the implementation of a governance structure with suitable metrics and measures).
- Lead the Quality Management Review process.
- Responsible for identifying and leading the continuous improvement of the company QMS.
- Implement and manage a vendor management program for qualification and oversight of GxP vendors.
- Manage the GxP audit program and conduct audits as required.
- Host regulatory inspections.
- Manage quality aspects for the identification and setup of new drug product manufacturing sites for supply of development products to company or investigator sponsored clinical trials.
- Oversight and management of the finished product labelling process.
- Maintain knowledge and awareness of developments in appliable, global GxP impacting pharmaceutical regulations and guidance. Assess their impact for the Company and initiate changes to Company processes and procedures as appropriate.
- Assess and document complaints and deviations to ensure adequate action is taken to rectify issues with the aim to prevent recurrence.
- Responsible for the management of recalls and Field Alert Reports for US products.
- Manage, develop and motivate a skilled and appropriately experienced quality function, ensuring adequate resource in support of QA activities.
- Implement and manage a system of training to ensure that all staff are trained to conduct GxP responsibilities in alignment with their job description.
- Act as an internal consultant and key point of contact for all GxP compliance issues, queries and guidance.
- Provide advice and encouragement to staff to ensure individual and company compliance. Provide training to staff on general or specific quality topics as appropriate.
- Provide input to the Company financial forecast and manage the QA budget.
Experience:
- Significant experience in development, manufacturing and quality aspects of sterile pharmaceuticals, preferably including radiopharmaceuticals.
- Experience of interactions with regulatory agencies, (FDA, EMA and/or national EU agencies) including inspections, scientific meetings and responding to review questions.
- Experienced in the design, implementation and operation of Quality Management Systems.
- Experience leading a team of QA professionals to achieve the best results for the organisation.
If you are interested then please apply or send your CV's to