Pharmaceutical Quality Assurance Manager

Cleveland Clinic London; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading healthcare provider in Greater London seeks an experienced Pharmaceutical Quality Assurance Manager to oversee all Quality Assurance aspects within the Pharmacy Department. You will manage the PQMS in compliance with GMP and GCP while enhancing service quality. Key responsibilities include conducting audits, leading training programs, and ensuring adherence to regulatory standards. This is an opportunity to work with a dedicated team committed to improving patient care and safety.

Benefits

Professional development opportunities

Collaborative work environment

Qualifications

• Strong knowledge of regulatory compliance frameworks (e.g., MHRA, GPhC).
• Registered as a Qualified Person.
• GPhC Registration as Pharmacy Technician or Pharmacist.

Responsibilities

• Ensure compliance with GPhC standards and MHRA licensing.
• Conduct internal audits and host external audits.
• Manage the quality management system for sterile and non-sterile services.

Skills

Hospital Pharmacy experience

Knowledge of pharmaceutical legislation

Ability to lead multidisciplinary teams

Familiarity with EPIC or major EHR

Education

Postgraduate qualification in quality assurance

Pharmacy or relevant Science degree to masters level

Job description

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.

About us

Cleveland Clinic London offers a brand-new high-acuity environment with the very latest equipment, where caregivers are encouraged to grow their expertise across multiple specialties, and in collaboration with expert clinicians. Our Mission, Caring for life, researching for health, and educating those who serve, assures our unwavering commitment to professional development.

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. This service may include the provision of chemotherapy, TPN, CIVAS, and investigational medicinal products as well as repackaging of non-sterile formulations.

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. This may include generation of business plans/cases/capital bids.

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.

Review and develop training in aseptic techniques for new staff and supervise newly validated staff during aseptic production.

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

To manage time effectively when there may be competing demands for attention and to work independently and accurately when under pressure.

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.

Ensure that any deficiencies identified are rectified promptly.

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.

As part of the final check/release role ensure environmental monitoring, cleaning and operator validations have been undertaken. 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.

Excellent interpersonal skills to ensure audit findings are a true representation.

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, National guidance, best standards to encourage best practice and maximise the efficiency of the department.

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, ensuring staffing aligns with service needs and strategic growth.

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. Undertake one-to-one appraisals, undertake APR, approve overtime and lieu time, manage annual leave, sickness, absence, recruitment and retention, training and initial stages of grievance and disciplinary procedures.

Be responsible for the self- development of skills and competencies through participation in learning and development activities, and to maintain up to date technical and professional knowledge relevant to the post

Appropriate support of Pharmacy staff undertaking Quality Assurance roles.

Act as a role model for junior Pharmacy staff.

To take full management responsibility of the team, providing leadership, recognising and developing the teams, mentoring, coaching and training them to utilise the strengths to enhance the departments performance and build organisational capability.

Assessing staff performance against agreed performance standards/objectives and/or competencies at least annually and develop meaningful and achievable personal development plans and objectives.

To be responsible for the self- development of skills and competencies through participation in learning and development activities, and to maintain up to date technical and professional knowledge relevant to the post.

Strategic Planning & Service Development

Contribute to the strategic vision and delivery of Pharmacy Services within Cleveland Clinic London, supporting integration with broader hospital goals.

Lead transformation and modernisation projects such as workflow redesign, automation, and digital integration.

Use internal metrics and external benchmarking (e.g., NHS, private sector comparators) 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, ensuring lessons learned is translated into system improvements.

Support organisational readiness for regulatory inspections, acting as subject matter expert in operational pharmacy practices.

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

Experience

• Hospital Pharmacy experience.
• Strong knowledge of pharmaceutical legislation (Human Medicines Regulations, GDP, COSHH) and regulatory compliance frameworks (e.g., MHRA, GPhC, CQC).
• Ability to live and lead the values of Cleveland Clinic London: quality and safety, empathy, teamwork, integrity, inclusion, and innovation.
• 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 (formerly known as CRB) to check for any previous criminal convictions.