Qualified Person

Position Summary
This position is offered as a contract/consultancy role. The Qualified Person will provide QP certification, compliance oversight, and expert GMP support on an as-needed basis. Hours are highly flexible and can be adjusted according to operational demands, project timelines, and batch release schedules.

The Qualified Person (QP) is responsible for ensuring that each batch of Investigational Medicinal Product (IMP) manufactured, packaged, labelled, or imported, as well as shipped under the company's MIA(IMP) complies with EU GMP (including Annex 13/Annex 16), UK Human Medicines Regulations, the clinical trial protocol, and MA/CTA requirements.

The QP provides independent oversight, performs batch certification, and ensures that the Quality Management System (QMS) supports the safe supply of IMPs for use in clinical trials in the UK and globally.

Essential Functions

1. Batch Certification & Release

Perform QP certification of IMP batches in accordance with Annex 16 and internal procedures.Ensure all manufacturing, packaging, labelling, testing, and importation steps meet GMP and CTA/MA requirements.Confirm compliance of each batch with the clinical trial protocol, IMPD, Technical Agreement, and QP declaration for imported products.Ensure timely release to meet clinical supply timelines.

1. Quality Oversight

Provide independent QP oversight across manufacturing, testing, packaging, labelling, storage, and distribution activities for IMPs.Ensure adherence to EU GMP, MHRA expectations, ICH Q7, ICH Q9, ICH Q10, and other regulatory guidelines.Approve and review batch records, deviations, OOS, CAPA, change controls, investigations, and risk assessments associated with IMP activities.Oversee the segregation and control of blinded/unblinded materials.

1. Importation & QP Declaration

For imported IMPs, ensure confirmation of GMP equivalence and issuance of the QP declaration, supported by evidence from GMP audits of third-country manufacturers.Review and approve Technical/Quality Agreements with contract manufacturers, contract labs, and distributors.

1. Audits & Compliance

Support internal and external GMP audits of CMOs, contract labs, packaging sites, storage facilities, and distributors.Host and respond to MHRA inspections, ensuring readiness and compliance at all times.Ensure QMS elements (complaints, deviations, CAPA, change control, supplier qualification, stability, document control) are maintained in a compliant state.

1. Technical Leadership

Provide expert advice on IMP manufacturing, blinding, randomisation, packaging processes, comparators, and auxiliary products.Contribute to the design, approval, and ongoing improvement of GMP procedures, batch record templates, and clinical supply workflows.Provide QP input into new product introductions, technology transfers, and protocol changes.

1. Training & Mentoring

Deliver GMP training to operational and QA personnel.Coach QP trainees and contribute to developing internal QP capability where required.

1. Continuous Improvement

Drive improvements in quality systems, operational efficiency, and data integrity.Support digital QMS implementation and GMP-readiness projects where applicable.Key Relationships:  Heads of DepartmentSenior ManagementQuality AssuranceExternal Contractors (including specialists) and Clients/SponsorsTravel requirements:
This role requires travel to the MedPharm UK site on at least a three/six-monthly basis to support operational and quality oversight responsibilities.

Education and ExperienceEligible for nomination as a QP under Directive 2001/83/EC, 2001/20/EC, and UK Human Medicines Regulations 2012.Registered on a UK QP eligibility list and named or eligible to be named on the company's MIA(IMP).Extensive knowledge of EU GMP, Annex 13, Annex 16, MHRA Guidance for IMPs, and ICH guidelines.Extensive experience supporting clinical trials, including IMP manufacture, packaging, labelling, importation, release, and compliance with CTA requirements.Demonstrated experience with semi-solid, solid and transdermal dosage forms, including:Impregnated matrices Liquid for external and internal use Transdermal patchesTopical creams, ointments, gels, lotions, and solutionsSuppositories Knowledge of GCP as applicable to clinical supplies.Experience with global CTA submissions and QP declarations for third-party sites.Demonstrated experience with manufacturing, packaging, labelling, testing, importation, and release of IMPs.Experience working with CMOs, contract labs, and global clinical supply chains.Strong understanding of randomisation/blinding, stability programmes, comparator sourcing, and clinical trial regulatory frameworks.Excellent decision-making, problem-solving, and communication skills.Knowledge, Skills, and AbilitiesIndependent, objective decision-making.High level of integrity and ethics.Strong cross-functional collaboration.Ability to communicate complex regulatory requirements clearly.Detail-oriented with a strategic perspective.Ability to work efficiently under pressure to meet clinical timelinesPhysical Demands and Work EnvironmentN/AOther Duties 
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

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