Qualified Person

Description:

MAC Clinical Research, a global full-service Contract Research Organisation (CRO) and research site network, is looking to appoint a Qualified Person (QP) to play a pivotal role in ensuring the safe and compliant certification and release of Investigational Medicinal Products (IMP). The position is based primarily at their Leeds site, with regular visits to Manchester and the flexibility for remote working as appropriate.

The QP will operate under the MIA IMP licence and in alignment with Directive 2001/20/EC Article 13. This role involves both hands-on responsibilities in product certification and leadership in quality and GMP compliance across the organization. MAC Clinical Research prides itself on putting people first, promoting well-being, and delivering exceptional service in a supportive, progressive environment.

Key Responsibilities:

• Certify IMP under MIA IMP licence as per Directive 2001/20/EC Article 13.

• Fulfill QP duties in accordance with Article 51 of Directive 2001/83/EC and UK regulations.

• Ensure IMP release for clinical trials aligns with Article 9 of 2001/20/EC.

• Ensure MIA IMP licence compliance and oversee the Quality Management System (QMS).

• Coordinate with contract/trainee QPs to manage workload and responsibilities.

• Review and approve Technical Quality Agreements, Batch Records, CTA, PSF, and IMP labels in line with Annex 13.

• Handle product complaints, deviations, and recalls.

• Perform and support GMP audits and participate in sponsor inspections and audits.

• Deliver GMP training and incorporate new regulations into company procedures.

• Ensure adherence to SI 2004 no. 1031 and relevant amendments, including Good Clinical Practice.

Key Skills and Qualifications:

• Degree in Pharmacy, Biological, or Chemical Sciences.

• Membership in a recognized professional body (e.g., RPS GB, RSC, or IoB).

• Minimum 2 years of experience in Clinical Trials within the pharmaceutical industry.

• Prior experience in CRO, hospital pharmacy, or a Phase 1 unit.

• Eligibility to act as a QP and be named on the MIA IMP Licence.

Physical Work Environment and Travel:

• Travel between MAC sites is required for QP activities and participation in meetings and problem-solving sessions. Occasional out-of-hours work may also be required, on a pre-arranged basis.

Benefits:

• Competitive industry-aligned salary

• Health insurance coverage

• Free onsite parking

• 25 days annual leave (increasing to 30 after 6 years of service)

• Your birthday off