Pharmaceutical Quality Assurance Manager

The Pharmaceutical Quality Assurance Manager will be responsible for all aspects of Quality Assurance within the Pharmacy Department specifically the unit dose packaging and the aseptic unit. The role includes strategic workforce management, service improvement and budget oversight, working closely with clinical, operational and corporate teams, along with the responsibility for establishing and managing all aspects of the Pharmaceutical Quality Management System (PQMS) in line with GMP requirements.

Main duties of the job

• Provide PQMS to support the comprehensive pharmacy production services provided to the hospital, ensuring compliance with current directives, legislation, external audit findings, GMP, GCP, GDP and Health and Safety.
• Review and develop training in aseptic techniques for new staff and supervise newly validated staff during aseptic production.
• Responsible for ensuring procedures are in place for the use of all equipment used within the department and that staff are trained in its use.
• Manage the quality management system for all aspects of the sterile and non-sterile services.
• Conduct internal audits and host audits by external bodies as well as regulators.

Job responsibilities

• Quality Assurance
  • Provide PQMS to support the comprehensive pharmacy production services provided to the hospital, ensuring compliance with current directives, legislation, external audit findings, GMP, GCP, GDP and Health and Safety.
  • Interpret and implement National Guidance and regulatory requirements relating to aseptic services, repackaging and Quality Assurance to develop and maintain SOPs and policies for the safe and efficient manufacture of suitable products.
  • Continue to develop the PQMS to support pharmacy services provided to CCL to improve the quality of patient care and services in line with the objectives of the hospital and the needs of our patients.
  • Manage the PQMS in relation to provision of aseptic and repackaging services to external customers and further develop these services in accordance with the organisational business plans.
  • Responsible for management of Technical / Quality Agreements with third party suppliers and customers.
  • Maintain effective communication between the technical production team and quality control/assurance staff members within the department.
  • Ensure a sufficiently robust capacity plan is in place and implement measures to ensure capacity is not exceeded.
  • Good business acumen to improve business efficiency and compliance.
  • Comment on CCF, CCL, local and regional policies relating to areas of expertise.
  • Ensure that any complaints are investigated promptly with outcomes communicated to stakeholders.
  • To support research and development within the departments and be aware of, adhere to and promote research governance.
• Training and Staff Development
  • Review and develop competency-based training programmes and validation procedures for staff working within pharmacy production services.
  • Ensure all staff are adequately trained and are competent in the work they perform.
  • Supervise the validation work of other staff as necessary.
  • Undertake Continuing Professional Development to maintain specialist knowledge in the fields of production services and GMP as well as GCP, GDP.
  • Performance will be formally reviewed, training needs identified and objectives agreed every 12 months as part of the Annual performance review scheme.
  • Complete the aseptic services training and accreditation programme according to the role requirements.
• Finance and resource management
  • Write specifications for capital equipment and review tenders to ensure that equipment purchase is of the required quality and represents good value for money.
  • Responsible for ensuring procedures are in place for the use of all equipment used within the department and that staff are trained in its use.
  • Responsible for approving Service Level Agreements and technical contracts with equipment and facility maintenance companies and ensuring that these are adhered to.
  • Ensure data is managed appropriately within the service.
• Operational Leadership
  • Manage the quality management system for all aspects of the sterile and non-sterile services.
  • Ensure appropriate documentation and records are maintained and are accessible.
  • Review all procedures and documentation at the required frequency to ensure that they are current, relevant, validated and meet current regulatory requirements.
  • Ensure all staff are kept up to date with procedural changes.
  • Responsible for ensuring all quality assurance tasks necessary for the running of a production unit are carried out and that this work whether performed in-house or by external organisations meets the standards required by the MHRA.
  • Prepare and manage the annual internal audit plan and perform regular internal audits, provide reports and approve CAPAs proposed in response to deficiencies raised.
  • Ensure the site master file is maintained and updated.
  • Responsible for ensuring service contracts for equipment and external services exist and that equipment is maintained properly.
  • Ensure appropriate storage and quality of raw materials and storage of final products.
  • Collate and act upon relevant product information such as stability data and COSHH.
  • Take action to resolve any out of specification results before products are released.
  • Responsible for trend analysis of environmental parameters is undertaken to identify critical control points and implement any actions that may be required.
  • Responsible for appropriate control of cleanroom environments.
  • Responsible for escalation and management of internal and external errors.
• Audit
  • Conduct internal audits and host audits by external bodies as well as regulators.
  • Prepare action plans in response to regulatory inspections and external audits.
  • Identify areas for audit and co-ordinate audits to ensure adherence to GMP, GCP, GDP and other regulations.
  • Critically evaluate the quality systems during internal audit.
  • Participate in and contribute to multi-disciplinary audit.
• Workforce & People Management
  • Provide direct line management and professional leadership to the Quality assurance team.
  • Champion a high-performing, inclusive culture with a focus on well-being, equity, and continuous development.
  • Lead workforce planning, recruitment, onboarding, and ongoing performance management.
  • Develop team capability through tailored training, mentoring, and succession planning.
  • Line management of the Lead QA technician and other nominated staff with Quality Assurance responsibilities.
  • Be responsible for the self-development of skills and competencies through participation in learning and development activities.
  • Act as a role model for junior Pharmacy staff.
  • Assessing staff performance against agreed performance standards/objectives and/or competencies at least annually.
• Strategic Planning & Service Development
  • Contribute to the strategic vision and delivery of Pharmacy Services within Cleveland Clinic London.
  • Lead transformation and modernisation projects such as workflow redesign, automation, and digital integration.
  • Use internal metrics and external benchmarking to identify opportunities for improvement and innovation.
  • Work in collaboration with leadership and commissioning functions to support service-level agreements (SLAs) and business growth.
• Compliance
  • Ensure compliance with GPhC standards, MHRA licensing, CQC regulations, and Cleveland Clinics Quality and Safety framework.
  • Lead investigations into incidents, complaints, and near-misses.
  • Support organisational readiness for regulatory inspections.
• Communication & Relationship Management
  • Act as an expert Pharmaceutical Quality representative, maintaining strong relationships with clinical leadership, nursing, supply chain, estates & facilities, and external providers.
  • Present reports, operational KPIs, and strategic updates to the Pharmacy Senior Leadership Team and relevant governance boards.
  • Participate in cross-functional meetings and external forums to contribute to national best practices and private sector benchmarking.

Person Specification

• Hospital Pharmacy experience.
• Strong knowledge of pharmaceutical legislation and regulatory compliance frameworks.
• Ability to live and lead the values of Cleveland Clinic London.
• Must work effectively across multidisciplinary teams with minimal supervision.
• Postgraduate qualification in healthcare management, pharmacy leadership, or supply chain management.
• Familiarity with EPIC or other major EHR/medicines management platforms.
• Experience in a private healthcare setting or familiarity with NHS/private sector interfaces.

Qualifications

• Postgraduate qualification in quality assurance.
• Registered as a Qualified Person.
• GPhC Registration as Pharmacy Technician or Pharmacist.
• Pharmacy or relevant Science degree to masters level.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.